Bundesanstalt für

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und -prüfung

Damage analysis on a 12200 Berlin

T: +49 30 8104-0

Cervical spine disc endoprosthesis type M6-C F: +49 30 8104-7 2222

File number: BAM-20045220

Scope: 52 Seiten
Execution: 5 von 5 vom 2022-02-23;
Distributor: 1.-5. Auftraggeber
6. Ausfertigung; BAM-9. iSA
Client: Landgericht Düsseldorf
Werdener Straße 1. 40227 Düsseldorf
Order from: 23.11.2020 gern. Beweisbeschlüsse v. 31.3. u. 17.5. 2020
Sign: 3 0 355/17 Euchler, C. ./. Spinal Kinetics GmbH

Subject of the expert Medical device expert report on a design defect, manufacturing
opinion:: defect and/or material defect of an M5-C intervertebral disc
prosthesis.
Documents:
Test pieces: Court file, 37 annexes received 28.5. and 21.7.2021 Damaged part
cervical spine disc prosthesis M5-C. Type FG 0002-01,

Type FG 0002-01. serial number AAG79(3) (3 not readable)

Investigations: Comparison part serial number AAD958

Collection of the test kit
Storage of samples
Collection / Destruction
Summary:
Study of files, literature, visual, fracto- and metallographic
examinations, chemical analysis, hardness testing The material
samples taken from the damaged parts will be kept until
31.12.2032, after which they will be destroyed without further
notice. The remains of the damage part and the settlement part
are sent to the court.
Manufacturing defects were found on the damaged part and
the comparison part, especially on the weld seams of the
titanium plates. The polymer components were not available
and could not be examined.

This report may only be published in its entirety and without additions. The revocable written consent of BAM
must be obtained in advance for any altered reproduction and for excerpts. The content of the expert report
relates exclusively to the objects assessed.

2015-04 / 2017-12-05 / BAM-9.1

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Table of contents

1 Subject of the investigations .........................................................4

1.1 Original DECISION I of 31.03.2020 (GA BI. 310) 4
1.2 Original DECISION II of 17.06.2020 (GA BI. 325) 4
1.3 LG DÜ asks BAM on 7.8.2020 to consider Annex B3 Decision on evidence of 5
1.4 31.03.2020 Question II. differentiated into individual technical questions
Chronology 5
1.5 Abbreviations, coordinates 5
1.6 7

2 Inventory ................................................................................ 8
2.1 Damage case and legal dispute Mr. Kleiner LG Dortmund 8
2.1.1 Expert opinion SV Prof. Bader Annex B3 (GA BI. 351 to 394) 9
2.1.2 Evaluation expert opinion Prof. Bader 9
2.2 Case of damage and litigation Kraftschik v. Spinal l<inetics LG Bochum 9
2.2.1 Expert opinion of Prof. Wilke in the legal dispute Kraftschik ./. Spinal Kinetics LG Bochum
2018-08-15 10
2.2.2 Statement by Prof. Schönmayr in the legal dispute l<raftschik ./. Spinal Kinetics LG
Bochum 2018-08-18 11
2.3 Information of the manufacturer SpinalKinetics about M6- 11
C
2.3.1 Variants of the disc endoprosthesis SKCD M6-C 11
2.3.2 Development Goal Spinal Kinetics 2005 and 2006 12
2.3.3 Examinations at Spinal Kinetics (SK) 12
2.3.4 Production documentation 13
2.3.5 Structure 13
2.3.6 Individual parts 14
2.3.7 Target materials according to manufacturer 16
2.4 Literature research Study of 16
2.5 medical records Incoming 17
2.6 documentation 22
2.6.1 Input status 22
2.6.2 Incoming documentation of the damaged parts cover plate and end plate 23
2.6.3 Position of the damaged parts in the X-ray image 23
2.6.4 Geometry of the damaged parts 24

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3 Material tests and their evaluation ............................ 25

3.1 Microscopic examinations 25

3.2 Fractographic examination: fracture mechanisms of the end plates 26

3.2.1 Macroscopic features 25
3.2.2 Microscopic features 29
3.2.3 Summary of the fracture mechanisms at P1 and P2 38
3.3 Metallographic examination: material structure 40
3.3.1 Sampling Separation Preparation 40
3.3.2 Microstructure 41
3.3.3 Tears 41
3.3.4 Coating 42
;

3.3.5 Weld seams 45

3.4 Chemical analysis of the Ti alloy 56
3.5 Mechanical properties Damage part P1, hardness test 57

4 Loads and construction........................................................... 58

4.1 Loads, stresses Comparative 58
4.2 tests 58
:: 4.3 Construction 58

5 Beantwortung der Fragen ................................................................... 50

5.1 To II: Revision rate 50
5.2 To 11.1: Design faults To 11.2: 60
5.3 Manufacturing faults 60
5.4 To 11.3: Material defects 61
5.5 To 11.4. to 11.7 Polymer components 61

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1 Subject of the investigations

A legal dispute between Euchler, C . ./ Spinal Kinetics GmbH concerning an M6-C intervertebral
disc prosthesis is being heard at the Düsseldorf Regional Court under 3 0 365/17. BAM was
commissioned by order of 23.11.2020 and reference to the evidence order of 31.03.2020 to
investigate a possible design and/or, manufacturing and/or material defect and to prepare an
expert opinion.
1.1 Original DECISION I of 31.03.2020 (CA BI. 310)
1.
The Parties are advised that - notwithstanding the drafting of the Order to take evidence -
the Chamber has not yet formed a final opinion on whether the ECJ case law cited by the
Claimant applies to the M6 disc prosthesis at issue.
II.
Evidence is (first) to be taken on the claim of the plaintiff that the product series of the
defendant's M6 intervertebral disc prosthesis implanted in her on the occasion of the
intervention in November 2009 in the Reha Schön-Klinik Hamburg-Eilbek and/or this specific
M6 intervertebral disc prosthesis itself is provided with a potential defect, for example
because it caused an increased revision rate due to a design and/or manufacturing and/or
material defect, e.g. due to the material used and/or the material used. e.g. due to the
material used and/or the guidance of the safety thread as well as due to the fixation and/or
securing and/or labelling of the polymer core, by obtaining a medical device expert opinion.
expert opinion.
III.
The expert opinion shall only be obtained if the plaintiff pays an advance payment of €
:: 5,000.00 to the court cashier in Düsseldorf within one month.
IV.
The BAM - Federal Institute for Materials Research and Testing - in Berlin is requested to
nominate one of its employees who is suitable and willing to prepare the expert opinion.
V.
The plaintiff is ordered to submit the M6 intervertebral disc prosthesis, which was apparently
removed during the revision surgery in autumn 2016 at the Charite in Berlin, to the court files
within one month.
1.2 Original ORDER 11 of 17.06.2020 (GA BI. 325)
1.
Dr.-lng. Christian Klinger is appointed as the main expert to answer the questions from the
evidence order of 31 March 2020 and Matthias Eli and Lothar Buchta - each to be summoned
via BAM, Unter den Eichen 87, 12205 Berlin - are appointed as further experts.

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II.
Proceed in the manner proposed by the Principal Expert.
III.
The preparation of the expert report shall not commence until the plaintiff's side has paid an
advance payment of € 14,000.00 to the cashier of the court, which is hereby
is hereby ordered.

1.3 LG DÜ asks BAM on 7.8.2020 to observe Annex B3

By letter dated 7.8.2020, LG DÜ (litigation 3 0 365/17) asks BAM to consider Annex B3, the
expert opinion of Prof. Dr.-med. Dipl. Ing. Rainer Bader of 8 June 2020 from the parallel
proceedings LG Dortmund (Ref.: 12 0 251/16) (action for damages due to an M6-C
implant) in the legal dispute between the plaintiff Sebastian Kleiner and St. Barbara-Klinik
Hamm Heessen. a.o.

1.4 Decision on evidence of 31.03.2020 Question II. differentiated into individual technical
questions
II.... the Spinal Kinetics M6 disc prosthesis had an increased revision rate due to a
11.1 Design defect and/or
11.2 Manufacturing defects and/or
11.3 material defects due to
11.4 the material used and/or
; 11.5 the guidance of the safety thread (polyethylene) and because of
11.6 the fixing and/or securing and/or
11.7 Marking of the polymer core (polyurethane).
According to the decision of evidence, design and/or manufacturing and/or
material defects (i.e. according to VDl3822 material, manufacturing and construction defects)
but not implantation and operating faults. Consequently, the
cause of the fracture cannot be determined and may not be stated in the expert opinion.
be stated.

1.5 Chronology

2020-03-31 LG DÜ Resolution-I: BAM may propose experts Proposal of

2020-05-06 possible BAM experts to the LG DÜ Original evidence
2020-05-31 resolution (GA BI. 310)

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2020-05-17 LG DÜ decision II, appointment of BAM experts: Klinger, Eli, Buchta.

Receipt of extensive expert report on comparable case pending at Dortmund

2020-08-18 Regional Court.

File returned at the request of the court. "New extensive files have been
2020-10-05 received by the court".

Remaining material was sent to LG, further advance on expert opinion was
2020-11-17 transferred to court cashier GA BI. 454.

Court file with order of 23.11.2020 (= decision II) and parts of damage received
2020-11-30 at BAM Parts of damage are incomplete, only metal implant parts, "implant-
bone sludge" was disposed of during the revision surgery. In addition,
fragments and screws, presumably from a steel stiffening implant, were
enclosed. Court file, damage parts and a folder "Patient files Euchler I" with X-
ray examinations from 2002 to 2011 and a folder "Patient files Euchler II" with
X-ray examinations from 2016 to date received.

Start of file study and literature research (examination A)

2020-12-01 Initial documentation and start of microscopic examinations (B)

2020-12-15 Fractographic examinations (B)

2021-01-13 Letter from BAM to LG DÜ with information on the metal fragments received,
2021-01-15 the missing plastic components and request for drawings, documents and
comparative part.
;
Letter from LG DÜ with annex from RA Jellentrup: Load cycles should not be
2021-02-17 examined.

Scanning electron microscopic examinations of the cover plates for

2021-02-23 fractography (B)

Call BAM at court LG DÜ: Ms. Häger writes a note to the colleague with the file
2021-04-25 and asks her for a reply to the BAM letter of 2021-01-15

LG DÜ to BAM for information: Deadline set for the parties

2021-04-27 Letter from the LG DÜ: Send documents and settlement part to the Düsseldorf
2021-05-28 Regional Court after the expert opinion.

Lawyer Mittelhuber sends cover letter + signatures + settlement part to

2021-05-28 BAM. + settlement part to BAM

2021-06-04 Repeated request for drawings and welding instructions to the LG DÜ

Measurements of the micro-geometry of the end plates

2021-06-22

2021-07-01 Topographical measurements on the damaged parts

2021-07-21 Technical drawings of the M5 disc received

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2021-08-05 Computer tomographic examination of the damaged and reference parts to

measure the weld geometry.

2021-08-20 Geometric measurement of the damaged and reference parts in the precision
measurement workshop

2027-10-25 Letter LG DÜ: Status report requested, 2021-11-05 Eing. BAM

2021-11-03 Determination of the section plane for metallography (C), metallographic
preparation and examination (C) and (F). Also due to the previous results of
the fractography, the weld seam between end and cover plate must be
additionally examined fracto- and metallographically.
(examination J).

2021-11-11 Letter from BAM with status to LG DÜ

2021-12-05 Chem. anal. (D) due to the geometry of the damaged part SEM/EDX.

1.6 Abbreviations, lcoordinates

LG = Landgericht
GA = Gerichtsakte
REM = Rasterelektronenmikroskop
REM-RE = Rasterelektronenmikroskop-Rückstreuelektronen
EDX = Energiedispersive Analyse
51< = SpinalKinetics

Sl<CD = Spinal Kinetics Cervical Disc lmplant

µCT = Mikro-Computer-Tomographie
WEZ = Wärmeeinflusszone im Bereich der Schweißnaht

To clearly identify the former position of the damaged parts in the body, a coordinate
system with the medical designations of all 5 sides was applied: anterior (front=mouth),
posterior (back=neck), sinister (left), dexter (right), cranial
(above=head), caudal (below=abdomen).

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2 Inventory
The client requested that previous expert opinions be taken into account, section 1.3. In the
following, the available expert opinions of comparable cases of damage of the same disc
prosthesis but of other patients are therefore evaluated.

2.1 Damage case and legal dispute Mr. l<leiner LG Dortmund

Mr Sebastian Kleiner was also implanted with an M5-C disc prosthesis in Nov. 2009, but in this
case in the "large" size. In June 2010, the X-ray findings were OK, but already in Oct. 2011, the Ti
plates were on top of each other. In Jan. 2015, the Ti plates were translationally displaced a.p.
on top of each other, but - as far as can be seen on the X-ray images, image 1 - they were not
broken. A legal dispute is being heard at the Dortmund Regional Court under 12 0 215/17.

Bild 1: X-ray lateral, Mr. Kleiner, disc prosthesis M5-C, end and cover plates lie
on top of each other, are not broken and show a clear offset, core and
sutures are missing between the plates [GA].

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2.1.1 Expert opinion SV Prof. Bader Annex B3 (GA BI. 351 to 394)
Prof. Bader evaluated the tests carried out at the manufacturer SK, first on 7 mm SKCD, later
also on 5 mm SKCD.
In the expert report, page 15, it is noted that the intervertebral disc prostheses provided by
SpinalKinetics for the approval were already partly faulty and therefore failed: "Tests for
lateral flexion / torsion were repeated as components were defectively manufactured on the
first attempt." [V0002 P Rev. 2. Functional and 7.SHz Kinematic Wear].
SK's own acceptance limit of 900 N/mm compressive stiffness was not met for all
specimens. With the justification of large scattering of the data in the literature, these
shortfalls were assessed as being within the acceptable range after the tests.
After many tests, Test V0025 Rev. 2. Static and Dynamic Verification is the first to test a 5
mm medium implant [Appendix 17, Test V0040 R] in addition to the 7 mm medium implants.
Result: ... In the dynamic □pressure test (pressure load 200 N - 2,000 N for 500,000 cycles at
10 Hz, n=4), fractures were detected in the weld seam of the metal plates at the pressure load
of 2,000 N. The implant was not tested in the dynamic □pressure test.
Furthermore, dynamic combined compression-shear tests and torsion tests were carried out
over
10 million cycles. The test pieces met the acceptance criteria. The 5 mm test pieces showed
cracks in the end plates at higher loads.
The 5 mm test pieces during the test with higher loads showed failure of individual securing
threads, but also of entire thread layers. The test results in Annex 17 [Report V0040 R]
describe 9 damages/discrepancies, which are justified with errors in the test execution. This
cannot be verified by BAM.
The types of failure of the test specimens summarised in Annex 15 [V0029 R, page 34 and 35,
tables] such as mechanical failure = cracks or fractures of the end plates and failure of the
securing threads and layers only occur at high, according to Spinal Kinetics, non-physiological
loads.
2.1.2 Evaluation of the expert opinion of Prof. Bader
Prof. Bader did not examine the damaged part for his expert opinion of 2020-05-08.
Therefore, nothing can be derived from his expert opinion for the question "material defect on
the intervertebral disc implant" to be clarified in the present case of damage to Mrs. Euchler.
Since a material defect according to VDI guideline 3822 also represents a product defect, he
could not have ruled out a product defect on Mr. Kleiner's intervertebral disc implant. Prof.
Bader does not write anything concrete about the possible causes of the implant failure in Mr.
Kleiner's case.
2.2 Case of damage and legal dispute l<raftschik ./. Spinal l<inetics LG Bochum
Only a photo, picture 2, and the expert opinions of Prof. Wilke, Prof. Schönmayr and Dr.
Holzwarth are available here on Ms Kraftschik's explant.

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In contrast to the rudimentary fragments of Ms Euchler's explant, picture 15, it is in much

better condition and obviously completely preserved.
None of the expert reports by Prof. Wilke and Prof. Schönmayr indicate that the defective
implant, Fig. 2, was examined with regard to the cause or mechanism of failure. Therefore,
nothing can be deduced from these expert opinions regarding a possible material defect.
Dr. Holzwarth's examination of the damaged part was limited to the material analysis of the Ti
plates. The weld seams or the thread ball, Fig. 2, were not examined.

Fig. 2: Damage case M6-C Ms Kraftschik: ball of thread in the top left of the
picture, part of the casing (top right) and core (in the bottom centre),
broken/cracked, in the bottom right of the picture it can be clearly seen
that the cover plates are still firmly connected to end plates [GA].

2.2.1 Expert opinion of Prof. Wilke in the legal dispute Kraftschik ./. Spinal Kinetics LG Bochum
2018-08-15

In his expert opinion, Prof. Wilke emphasises that the therapeutic advantages of the M6-C
outweigh the minor risks of suture breakage. Based on some literature, he states that the M6-
C implant has proven itself clinically. He argues against Dr Holzwarth because he assumed only
one thread to secure the core. In fact, however, 4 individual threads were installed in 4 layers.

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Prof. Wilke neither investigated nor explained the cause for the loss or slipping out of the
core of the M6-C of the patient Kraftschik.
The so-called clinical evaluation of the prosthesis of this design refers to literature with a 2-
year observation period.
Spinal Kinetics informed Prof. Wilke that a total of 42,426 patients had been fitted with the
M6-C disc prosthesis since its market launch in 2006 up to May 2018 and that Spinal Kinetics
had received a total of 133 reports of incidents during this period. Of these 133 reports, 53
reports related to cases where the prosthesis had "collapsed" (prosthesis core losing height
due to accelerated wear, resulting in less clearance or contact between the metallic cover
plates).
BAM comment: In the above-mentioned period, the design of the M6-C disc prosthesis was
changed at least twice, see Chap. 2.3.1.

2.2.2 Statement by Prof. Schönmayr in the legal dispute l<raftschik ./. Spinal Kinetics
LG Bochum 2018-08-18
Like Prof. Wilke, Prof. Schönmayr also argues with the "best kinematics" and the "lowest
implant displacement".
"lowest implant failure rate" and "fully shares Prof. Wilke's conclusion. The prosthesis used
for Ms Kraftschik offered the level of safety that doctors and patients could expect according
to the state of science at the time".
Between 2005 and 2012, about 600 patients were operated on in his clinic, in whom almost
1,000 M6-C prostheses were implanted, and Prof. Schönmayr is not aware of a single case of
implant failure.

2.3 Information from the manufacturer Spinall<inetics on M5-C

2.3.1 Variants of the disc endoprosthesis Sl<CD M5-C

The newer design FG 0002-01 with an overall height of 6 mm differs from the older design FG
0001-01 with overall heights of 7, 8 and 9 mm in particular by thinner end plates, other
welded connections between cover and end plates and the clamping of the sheath. As a
drawing of the 7 mm version is not available, the differences could only be taken from [Annex
4, section Q, memorandum 2006-07-18].
The 6 mm implant is available in the sizes (... footprint") medium and large.
RAin Mittelhuber 2021-05-26: The US manufacturer does not have a batch-matched sample
and no longer has any samples of the individual parts, as the version of the M6-C prosthesis
used by Ms Euchler was last manufactured in 2009. The lot documentation
[ ... "Lot History Record"] for the prosthesis implanted in Ms Euchler's case can be found as
Annex 24 in the attached folders." This attachment also documents lot H80001522 - FG
0002-01, which includes Ms. Euchler's M6-C with serial number SN AAG793.

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2.3.2 Development goal Spinal Kinetics 2005 and 2006

The 7 mm SKCD prosthesis should be brought to 6 mm height for physiological reasons
[Appendix 4 design history].
In Annex 5 ["2005-12-22_ProductSpec Rev5 SKCD"], under 5.1.3.3.1 "Assembly shall have an
appropriate stiffness of 737 ± 885 N/mm" is required. The specification of the compressive
stiffness of 737 ± 885 N/mm is technically incorrect, as stiffnesses do not physically allow a
change of sign. It also remains unclear how this range of values can be used as a failure
criterion in the tests of the SKCD.
From the literature [Moroney, S. P., j. Biomechanic Val. 21, Na. 9. pp. 769-779, 7988), it can be
concluded that the figure+/- 885 Nmm-1 is due to the small sample size and the high scatter
of the individual values.

2.3.3 Tests at Spinal Kinetics (SI<)

In Appendix 4 [,,Design history 5. 37 Process Validation page 5 of 9 at #72"] it is described that
the tang weld depth cannot be fully verified: "Depth of penetration not fully verifiable. Special
Process." For the interrupted pulsed laser weld "seam weid" a 100% quality control of both
welds is specified in report V0060P.
For the verification/validation of the M6-C intervertebral disc implant, SK defined, performed
and evaluated a series of tests. These were described and evaluated in the Bader expert report
[Annex 3 of the court file], cf. chapter 2.1.1.
In the evaluation of the test results by SK, a distinction was made between mechanical failure
and functional failure. According to the definition of the failure criterion "Number of intact
fibre layers" by SK, a functional failure [failure code F ... according to Table 8.1 in V0040 R]
only occurs when more than 2 of the 4 layers of threads are completely broken (failure code
F2). The breakage of individual 0".4 threads in only one layer, on the other hand, represents a
mechanical failure (failure code M3) ar.
SK's documentation showed thread breaks in various tests [V0040 R, 5. 19 of 35). In
particular, according to SK, excessive (...unphysiological") cyclic shear stresses lead to
Dyn. Compr. Shear" and dynamic torsion lead to this (error code M3) [V0040 R, 5. 25 of 35].
The dynamic compression test with 10 million cycles showed no thread breakage [V0040 R, 5.
21 of 35].
At higher loads and -70,000 cycles (Dynamic High Compression), breaks occurred at the weld
seam or cracks in the end plate [V0040 R, p. 22 of 35].
In summary, individual thread breaks, thread layer breaks as well as cracks and breaks in the
end plates occurred on the 6 mm SKCD, especially during cyclical tests with high test loads.
The loads tested were "compression, compression-shear, torsion", i.e. axial compression,
compression at an angle of 45° (compression and shear 1:1) and torsion. It is noticeable that
neither the cyclic lateral bending s-d nor the cyclic flexion / extension a-p of SK were defined
in V0040 P and according to V0040 R were not tested on the 6 mm size [Annex 17 V0040 R,
5. 15ff of 35].

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In 2005, 7 mm SKCD medium implants were tested with a dynamic flexion/extension

flexion/extension with superimposed lateral bending and torsional loading at 7.5 Hz for 10
million load cycles in 37°C deionised water [V0002P Rev-2]. The primary objective was to
determine the wear volume and residual stiffness. According to [V0002R], thread breaks
occurred, the criterion that at least 2 thread layers must remain intact remained fulfilled. It
remains unclear why the 6 mm implants with thinner endplates (worst-case) were not tested
with these flexion/extension and flexion loads, although the lateral flexions represent the more
critical load case.

2.3.4 Manufacturing documentation

According to RAin Mittelhuber, the fabrication documentation in Annex 17 was handed over as a
"Lot History Record". However, it was not possible to identify the defective part on the basis of
the serial number AAG79, presumably (3), since 3 was not legible, or the comparative part serial
number AAD968. The device serial numbers are N05120501-1...15 [5. 166/211 in Annex 17]. Some of
the information in the documentation is blacked out. In Annex 24 [Production Lot: H80001622,
Part Description SKCD ODW - 6mm Medium OUS] the damaged part can be found with the
"preasigned serial number" AAG793. The welding parameters for this batch are also documented
there. In the final inspection, 4 of 261 implants were rejected, but not AAG793. The final
sterilisation was carried out in ethylene oxide at 49° ( for 12 h, Annex 17 5. 170/211.

2.3.5 Set-up

Fig 3: Measures [SK] and structure [2008_Diss_Uni5aarland_Movement_analysis].

The basic structure of the M6-C cervical disc implant is shown in Figure 3. Size M has a
width of 15 mm, (anterior-dorsal) depth of 12.5 mm, thickness of 6 mm or 7 mm.

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Laserstrahl

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Figure 4: Sectional view: end plates (OEP) cover plates (IEP) [Appendix 4 - ,,DHF 0003 - Design History File -
SKCD 6 mm lmplant Design"] supplemented by the welds and laser beam directions: on the right for welding the
interrupted pulsed laser welds, on top for welding the tang welds

Figure S: Comparison part V, disc prosthesis 6M-C. Top view of the upper end plate with the tenon weld

2.3.6 Individual parts

Technical drawings of the individual components of the M6-C prosthesis were provided by SK.
Figure 6 and Figure 7 only show the drawings of the end and top plates.

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CONFIDENTIAL

Fig. 6: End plate (OEP) Drawing CP 0027-01, latest amendment 22.10.2008,

dimensions in mm added by BAM

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CONFIDENTIAL

Fig 7: Cover plate (IEP) Drawing CP 0028-01, latest amendment 27.06.2008,

dimensions in mm added by BAM

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2.3.7 Target materials according to manufacturer

Core:
Polycarbonate Polyurethane (PCU] - Durometer 550 - PTG's Bionate® -- Chronoflex C®
Fibres Fibre ring (securing threads]:
UHMW-PE (Ultra High Molecular Weight Polyethylene]: - Teleflex Force Fiber TM
Jacket(= Sheath [Spinal Kinetics]):
Polycarbonate Polyurethane (PCU): - Durometer BOA - PTG's Bionate® - - Chronoflex C®.
Endplates square with keels:
Ti6Al4V (Grade 5) according to ASTM F1472 Titanium Plasma Spray Coated
Cover plates round
Ti6Al4V (Grade 5) according to ASTM F1472
For the materials used, see document [PS 0001 Rev. 4 Annex 5]. SKCD Product Specification,
Item 9. Biocompatibility] a biocompatibility test in vitro and on vivo was carried out by the
defendant.

2.4 Literature review

The literature review on cervical disc prostheses generally found for similar clinical efficacy
compared to vertebral body fusion. At present, long-term studies have not proven that the
rate of adjacent segment degeneration observed with fusions is prevented and the revision
rate is lower in comparison. A statistically significant difference has not yet been
demonstrated [Scholz M. et al., The Spine 2018; 02: 309-330].
Most of the clinical results on cervical disc prostheses and the M6 C prosthesis were
collected in FDA studies at the time of approval [Scholz M. et al., The Spine 2018; 02:
309-330].
In the legal dispute Mr Kleiner/ LG Dortmund, Prof. Bader points out that he found no
evidence for a clustered failure or an increased clinical risk of the M6 C prosthesis even
compared to other cervical disc prostheses. He states: "A current risk assessment and a
post market surveillance analysis of current incidents and failures is not available to the SV.
Therefore, the assessment and the number of incidents reported by the defendant
concerning the M6-C implant cannot be assessed by the SV at the present time."
In the legal dispute Mr. Kraftschik / LG Bochum, Prof. Wilke reported inconspicuous revision
rates. According to the FDA report stated there, there are virtually no complications within
24 months.
In the publication [Brenke, C. et al, Eur Spine J (2015) 24 (5uppl 4):5536-5539], an implantation
of an M6-C prosthesis presumably identical in construction to the one presented here was
reported in 2007. After pain in 2012 with posterior displacement of the lower end plate, the
prosthesis was explanted in 2013 after 6 years.

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Intraoperatively, a defect of the fibres and a posteriorly displaced core were found at the
posterior end of the prosthesis. The authors speculate that the first failure is a fatigue failure
of the outer shell, which allows fluid to enter the prosthesis and damage the PE threads,
causing them to break and the core to emerge posteriorly.
The authors found no comparable reports of similar failure in the literature. They also point
out that in 2007 there was a design change with stronger fibres and modified endplate
anchorage of the fibres, cf. 2.3.1. They further report on
3 clinical studies with a total of 99 implantations in which no complications occurred. The
observation period here was again only 24 months.
In the literature [Pingel, A. et al, Z Orthop Unfall 2020, DOl 10.1055/a-1286-5172], another failure
of an M6-C prosthesis implanted in 2011 is described. Revision of the prosthesis 6 years
postoperatively revealed a completely torn fibrous ring posteriorly and a core dislocated
posteriorly into the spinal canal. A strong abrasion of the PE threads with subsequent tissue
reaction is assumed as a possible cause. The authors further state that the majority of long-
term outcomes after implantation of this type of prosthesis are satisfactory but also show a
certain susceptibility to fatigue fractures of the posterior polyethylene fibre shell, which can
lead to posterior core extrusion. Therefore, it seems reasonable to critically examine the
indication and to perform radiological long-term controls.
Medium-term failure of cervical M6-C prostheses due to PE wear particles is reported in the
current literature published online [Scott-Young, M., European Spine Journal, https://
doi.org/10.1007 /s00586-021-07094-7]. Over an average observation period of 5.5 years, 34% of
implanted prostheses were revised due to wear-related osteolysis. The cause of the osteolyses
is believed to be failure of the sheath and severe PE abrasion of the fibre threads.
It is not clear from the publication which design of the M6-C prosthesis was used in the studies
by Scott-Young, M. The failure mechanism is similar to that of the M6-C prosthesis. However,
the failure mechanism is similar to those described in the individual cases [Brenke, C.] and
[Pingel, A.].
For the design of the M6-C prosthesis explanted seven years postoperatively, implantation
time approx. seven years, no revision rates from medium- and long-term observation periods
were available. The medical efficacy is only proven on the basis of a monitoring period of two
years.

2.5 Study Medical records

Two folders, labelled "Patient File I" and "Patient File II", were received with the court file. They
mainly contain list printouts of treatments, doctors' letters, diagnoses and x-rays covering
the period from 11/2002 to 07/2017. The files were reviewed for the period from 11/2002 to
10/2016. An assignment of the implant and an assessment of the installation situation to
estimate whether the implant experienced high flexion angles a-p or s-d in the installation
state was carried out on the basis of the 12 CDs with X-ray, MRI and CT images.

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As a result of a determined malposition of the upper and middle cervical spine with damage
to the cervical vertebral bodies CS and C6 as well as a herniated intervertebral disc (see X-ray
findings of 30.07.2003 of the radiomed practice, Wiesbaden), a fusion of the cervical
vertebrae CS and C6 was carried out on 10.10.2003 by means of a plate cage implant.
Further findings with complaints of the cervical spine occurred in 2004 after an accident with
whiplash, in 2005 an accident with side impact and in 2006 a fall with a mountain bike.
Subsequently, a chronic cervical spine syndrome, degeneration of the vertebrae [6 and C7
below fused level, neck pain, carpal tunnel syndrome, root irritation at the C6 cervical vertebra,
a right-sided foraminal narrowing CS/6 and a herniated disc at the disc between C6 and C7
were diagnosed.
Figure 9 shows the findings - chronic pain due to unfavourable position of the fusion and a
spinal curvature - of the Dortmund spinal centre with the indication for surgery. A follow-up
fusion to the already fused vertebral bodies CS and C6 is not considered because of the young
age and the preservation of mobility. Implantation of an intervertebral disc prosthesis and
further assessment by the EndoKlinik Hamburg is recommended.

Fig 9: X-ray of the fused cervical vertebral bodies CS and C6 from 30.09.2009 of the
Wirbelzentrum Dortmund. Left X-ray a. p., right lateral

The M6-C intervertebral disc prosthesis was implanted at the Schön Kliniken, Klinikum Eilbek
Hamburg on 26.11.2009. Intraoperative images were only available as a copy, Figure 10.

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Figure 10: Intraoperative image. Left view in a. p., right lateral with almost parallel alignment of the end plates of
the M6-C prosthesis (circled in white).

The postoperative images of 30.11.2009 of the Eilbek Clinic and the discharge report of the
Nordsee Rehaklinikum II St. Peter-Ording, which according to the findings showed a correct
position of the implant, are not available here.
After an 80% improvement in the preoperative pain symptoms recorded in the outpatient
report of 3.2.2010 from the Schön Klinik, the Joint Centre Wiesbaden reported triceps
paralysis, thenar muscle weakness and thoracic spine blockage over a treatment period from
16.3.2010 to 13.1.2011.
The X-ray images taken in the Radiological Practice, Berlin, on 9.11.2011, Figure 11, are the first
postoperative images made available after implantation of the M6-C intervertebral disc
prosthesis. Biomechanically, a constant extension malposition with kyphosis was found in
the cervical vertebral body 5. According to the findings, there is subchondral sclerosis under
the cover plate of the 7th cervical vertebral body - a recognisable compression of the bone
tissue under the cartilage layer of a joint - osteolysis at the front and rear edge and a slight
implant collapse into the base plate of cervical vertebral body 6. A metal fracture or implant
dislocation was not observed.
Figure 11 shows the sectional views 4 and 6 in the a. p. view. The distance between the
implant plates from anterior to posterior decreases and the inclination of approx. 2° of the
upper to the lower implant plate as well as a lateral offset is visible on the right side of
picture 11.

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Figure 11: Postoperative X-ray images from 09.11.2011. On the left in the image, sectional image 4 of the CT
image a. p. In comparison, in sectional image 6 taken further dorsally, shown on the right, the distance between
the two end plates (1) and (2) is smaller and also shows a clear lateral offset and a skewed position of approx. 2°.

Compared to the intraoperative lateral view, picture 10 right, the two implant plates are no
longer parallel but open towards the breast in the X-ray images provided. Figure 12 on the left
shows the corresponding lateral overview image for Figure 11 on the left and on the right as CT
sectional image 19. They show an opening angle of approx. 8° towards the breast. In the
sectional image 79, the ventral position of the intervertebral disc replacement according to the
findings is clearly visible.
The static angles and also the translational offset of the M6-C prosthesis visible on the X-ray
images appear to be within or at the specified limits with 6° inclination in the a-p direction,
7.5° inclination in the lateral and 3.S mm translational offset.

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Figure 12: Postoperative lateral overview image from 09.11.2011 on the left and on the right, sectional image 19.
The implant plates show an opening angle of approx. 8° towards the breast and in the image on the right the
ventral position of the implant can also be seen.

Subsequently, apart from an MRI examination on 4.12.2011 in the radiology practice Berlin, no
further medical documents are available here until 8.7.2016. The condition of the implant
during this time can therefore not be assessed.
On the X-ray and MRI images of 8.7.2016 in image 13 of Radiology 360, Düsseldorf, the multiple
failure of the M6-C disc prosthesis is clearly visible, but is not documented in the findings. This
also applies to the subsequent MRI examination on 22.7.2016.
For the further documentation showing the failure of the M6-C prosthesis, an X-ray of
22.8.2016 of the Dortmund spinal centre was available. No findings were available for this. For
the first time, the failure was documented pictorially and also in the findings with destruction
and fracture during the MRI examination at Radiology 360, Düsseldorf, on 29.8.2016.

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