BAM

Bundesanstalt für
Materialforschung
und -prüfung

Picture 13: X-ray image from 8.7.2016. Left picture shows the a. p. image. Upper and lower plates lie on top of each
other, plates are broken and show a clear misalignment. Right picture shows the lateral x-ray. In contrast to the
previous images, the completely destroyed M6 prosthesis is no longer recognisable as such.

On 21.09.2016, the fractured disc prosthesis was removed at Charite Berlin and a

spinal fusion osteosynthesis C6/7 was performed.

2.6 Initial documentation

2.5.1 Initial condition

Euchlor
Ccline MZC 14
"J]Q].19]8 V;l
'"ai:: 31QJ41g;;�

Figure 14: Overview of the received damaged parts and incoming packaging.
The broken damaged parts were sent to BAM in a plastic tube and a plastic bag, Figure 14. The
plastic bag contained the parts of the disc endoprosthesis and 2 screws.
;;:

BAM-Gutachten Aktenzeichen: 2004S220 Seite 22 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

The plastic tube contained a part of a fastening element (screw-eye of the plate cage, see
chapter 2.5.3) and another small fragment of the disc prosthesis.

2.6.2 Incoming documentation of the damaged parts of the cover plate and end plate

The parts were visually sorted at BAM and named for further examination: the fragments
P1-1 and P7-2 belong to the lower (caudally located) outer end plate P1
(manufacturer's designation: "Duter Endplate" OEP); P2-1 and P2-2 belong to the upper
(cranial) outer endplate.
(cranial) outer end plate P2. The inner endplate (IEP) was designated T1, see Figure 15.

T1 P1-2 P1-1 P2-1 P2-2

s mm
1 I
Figure 75: Overview and designation of the examined damage parts/ fragments: Inner end plate T1, outer end
plates P1 and P2 Outer end plate

The whereabouts of the missing fragments of the cover plate T1, the second completely
missing cover plate and the plastic components (thread and sheath) could not be clarified on
the basis of the GA.
The analysis of the adherent white particles/coating on P1 visible in Fig. 15 in particular
revealed bone. This is an indication of good ingrowth of P1 into the vertebral body C7.
The weld at the hole of the cover plate T1 is completely reamed. The welds on the outer end
plates for connection to the inner cover plate were also not clearly attributable to T1. For this
reason, the fracture piece T1 could not be assigned to end plate P1 or P2.All fracture surfaces
of P1-1, P1-2, P2-1, P2-1, and T1 were fractographically examined with regard to the fracture
mechanism, cf. chapter 3.2.

2.6.3 Position of the damaged parts in the X-ray image

With the X-ray images received, it was also possible to reconstruct the position of the
damage fragments in the patient, Fig. 15. The stiffening of the C5/C5 vertebrae with the
plate cage, from which the two screws 57 and 52, cf. Fig. 14, and the screw eye also originate,
is clearly visible there.

BAM-Gutachten Aktenzeichen: 20045220 Seite 23 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

2016-07-08 Röntgen Euchler HWS stehenc

P2-2
ap tat

Figure 16: Damaged parts P2-1, P2-2, P1-2 and PH and their location in the X-ray image between the C6/C7 cervical
vertebrae.

2.6.4 Geometry of the damaged parts

Due to the small dimensions of the damaged parts, some dimensions were measured visually
and compared with the specifications in the drawings. In particular, it was necessary to clarify
whether the dimensions and the radii of the oval oblong holes on the cover plate - through
which the threads were looped - were correctly executed.

Fig. 17: Slotted holes of cover plate T1, glad. with l<EYENCE IM Series (IM-7500). Nominal tangential width= 0.813
mm,+ 0.051 / -0.025 mm.

The elongated holes are made according to the drawing, Fig. 17. The deviating diameter of 2
holes (with the values: 0.855 mm and 0.859 mm) could be due to the deformation caused by
the breaking process and the rubbing against the threads. The deviations are not significant,
Fig. 17.

BAM-Gutachten Aktenzeichen: 20045220 Seite 24 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

3 Material tests and their evaluation

3.1 Microscopic investigations

On both end plates P1 and P2, the surfaces of the inner side at the outer edge of the
interrupted weld seams a and p were possibly machined with the laser ablation process (Fig. 78,
Fig. 19 and Fig. 31). This surface treatment is not visible on the comparison part VP (Fig. 18),
where the surfaces appear polished. On the end plate P2, at the end of the left side a, from the
view to c, a machining notch with a clear height difference can be seen. This notch is so incisive
that a fatigue crack started here (Fig. 31) and led to a fatigue fracture. Also in the case of the
end plate P1-2 on side p, the crack starts correlate, among other things, with the machining
marks (Fig. 28). According to the technical drawing, Notes item 4 states the following, mutatis
mutandis:
"4) all surface finishes are critical and should be inspected".
The remaining machining marks were either not inspected or were classified as non-critical.
However, as they have caused fatigue cracks, they must be classified as critical.

Surfaces a and p of the inside of the

OuterPlate Pl P und VPl
BAM
d s
d s
a
p

1 mm, -, ----- a
1

Surface finish on sides a and p of end plate P1 (left, streaky

traces) in comparison with the end plate of the comparative part VP1 (polished
on the right).

BAM-Gutachten Aktenzeichen: 20045220 Seite 25 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Surfaces a and p of the inside of the

BAM
OuterPlate P2

Figure 19: Traces of surface treatment on the sides p (upper row of images) and a (lower row of images) of the
end plate P2

3.2 Fractographic investigation: Fracture mechanisms of the end plates

3.2.1 Macroscopic features

Of all the parts, the two screws (S1 and S2) are still in good condition, they are not broken.
The ring-shaped screw eye, which belongs to the plate cage, cf. 2.5.3, as well as other
smaller pieces, picture 20, rubbed strongly with other parts and therefore cannot provide a
meaningful result. Since these damaged parts, Figure 20, do not belong to the disputed
disc prosthesis, they were not examined further.

Screws S1 and S2

5mm
Ring presumably for stiffening of vertebrae CS/C6

Figure 20: Screws S1 and S2, and a ring-shaped screw_eye broken off from the plate cage. Macro photo.

BAM-Gutachten Aktenzeichen: 20045220 Seite 26 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

The cover and end plates, which were originally welded together, have been separated by
fractures. There are no macroscopically visible parts of these two plates still in contact. The top
plate T has broken into smaller pieces, of which only fragment Tl is included here, Figure 21. It is
heavily abraded at the central weld.
The fragments of the upper end plate P2 show that the plate is broken both in the centre and
at the corner where part of the plate was lost, Fig. 15.

BAM 5mm T1
1 1
Fig. 21: Only existing fragment of the cover plate Tl, top view from above and below, macro photos

BAM-Gutachten Aktenzeichen: 20045220 Seite 27 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Figure 22: Cracks in the end plate PH. Stereomicroscope

The lower end plate P1 is broken into 2 parts at one corner (a large PH and a small P1-2), picture
15. Small and short cracks could be found on the P1 at the edge as well as in the middle around
the central hole, picture 22. The inner surface of the hole of the end plate P1 (so called hole
reveal), where the weld should be, clearly shows machining marks that are not cracked, melted or
reamed, picture 23. This indicates that the welding process did not take place on this surface.

BAM-Gutachten Aktenzeichen: 20045220 Seite 28 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Figure 23: Hole reveal of end plate P1-1 with machining marks. Below solidification structures from the pulsed
laser of the pin weld, stereomicroscope

Obviously, fractures occur starting from one of the pulsed welds or cutting through the end
plate. The different crack initiation sites and directions as well as the crack mechanisms shall
be determined in the following by microscopic investigations using a scanning electron
microscope (SEM).

3.2.2 Microscopic features

3.2.2.1 Fracture surfaces at the weld seam

In addition to many abraded areas, small areas indicating fatigue fracture were found on the
central pin weld in the SEM, Figure 24.

BAM-Gutachten Aktenzeichen: 2004S220 Seite 29 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Latch lines

Figure 24: Latch lines on the fracture surfaces of the tang weld. (a) Overview; (b) enlargement of the red frame
in (a); (c) enlargement of the middle part of (b): fatigue fracture.

In the micrograph, these areas of the tang weld are also low in deformation, Fig. 47, which
also points to a fatigue fracture. In addition, the SEM images of the inner surface clearly
show surface machining with marks, again in agreement with the stereo image. The tenon
weld can be seen directly below the machining marks in Fig. 25.

BAM-Gutachten Aktenzeichen: 20045220 Seite 30 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

BAM

Figure 25: Hole reveal of end plate PH, tenon weld (most obvious on the right). SEM

Figure 26: Hole reveal with cracks at the tenon weld of end plate PH. (a)

Overview; (b) enlargement of the red frame in (a), machining marks.

Fatigue cracks have also started at the outer interrupted pulsed laser welds (seam welds).
Figure 27: Shooting slits at the crack initiation points and the direction of the detent lines on
the fracture surface indicate that the crack runs from the outside into the interior of plate
P2.

BAM-Gutachten Aktenzeichen: 20045220 Seite 31 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Latch linesn
Figure 27: Latch lines on the fracture surface of the interrupted pulsed laser weld P2d. (a) overview; (b)
enlargement of the red frame in (a); (c) enlargement of the yellow frame in (b): fatigue fracture

The interrupted welds P2d show fatigue fractures with no/ very little residual force, Figure
27.

3.2.2.2 Fracture surfaces of the end plate

As can be seen in Figure 28, the crack of the end plate P1 starts at the radius to the "hump".
Cracks are visible around the "hump", on the right in Figure 28. The enlargement of the
fracture surface of the fractured piece P1-2 clearly shows vibration fringes as well as
secondary cracks running parallel to the fringes. These are indicative of the vibration fracture
mechanism, Fig. 29.

Figure 28: Crack starts correlate with the surface finish on side p of the end plate P1-2, contact damage on
the "cusps" of the end plate

BAM-Gutachten Aktenzeichen: 20045220 Seite 32 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

(a ) P1-2 (b)

(c)

------0
Crack start

Vibration
stripes/
secondary
cracks

Figure 29: Vibration fracture of the end plate P1-2. (a) Overview; (b) magnification of the yellow frame in (a); (c)
magnification of the red frame in (b): SEM

The traces of detent lines and oscillating stripes are also clearly visible on the counterpart
P1-1, Fig. 30. Together with the findings of the fracture surface of P1-2, it is obvious that the
fracture is mainly an oscillating fracture. Due to the trituration, it is unfortunately not
possible to identify the residual violent fracture.

BAM-Gutachten Aktenzeichen: 20045220 Seite 33 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Figure 30: Vibration fracture of end plate P1-1. (a) Overview; (b) magnification of the blue frame in (a); (c)
magnification of the red frame in (b); (d) magnification of the yellow frame in (b). REM

Crack initiation from the surface a of the inside of BAM

the OuterPlate P2 in the SEM
,.,..,.,,--_....,.,,.....
d

fatigue fracture

Figure 31: clear traces of surface treatment on side a of end plate P2 led to crack initiation and continuous
fatigue fracture

BAM-Gutachten Aktenzeichen: 20045220 Seite 34 von 52

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Region 1
/ \ . . _fa)
' ...�:\ ·0.
'�-�--::� 5i� ·---�

(c) Region 1

Figure 32: Overview of the damaged part of the P2-1 end plate (OuterEndPlate). (a) SEM; (b) macro photo; (c)
region 1 of (a), SEM.

Unlike the single crack at the corner of the end plate P1, Figure 22, P2 is fractured in more than
two parts in the middle by the central hole. The surface of the hole itself is also fracture
surface, but heavily abraded and therefore not shown. Close inspection of the inside near the
fracture surface P2-1 reveals the machining marks, which correspond exactly to the crack
initiation, Figure 31. SEM examination further revealed that the fracture propagating from this
machining trace. is an oscillatory fracture. Vibration fringes could also be found near the
coating at the end of the crack propagation, also indicative of fatigue fracture, Figure 32 and
Figure 33 a and b. The small area of residual violent fracture exhibited a ductile honeycomb
microstructure, Figure 33 c and d.
On the fracture surface of piece P2-2, only two regions (3 and 4) can be analysed
microfractographically, Figure 34. Region 3 clearly shows vibration fringes and crack initiation
from the inner surface and crack propagation outwards to the coating, Figure 35.

BAM-Gutachten Aktenzeichen: 20045220 Seite 35 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Figure 33: Details of the fracture surfaces framed in colour in Figure 32. (a) Enlargement of the red frame in Fig. 32,
(b) enlargement of the yellow frame in (a), oscillating stripes and secondary cracks; (c) enlargement of the purple
frame in Fig. 32; (d) enlargement of middle area of (c), honeycombs. REMRE.

Figure 34: Overview of the damaged part of the end plate P2-2 with the mentioned regions 1 to
4.

BAM-Gutachten Aktenzeichen: 20045220 Seite 36 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Figure 35: Details of fracture surfaces P2-2: (a) overview of region 3 in Figure 34, (b) magnification of the yellow
frame in (a); (c) magnification of the red frame in (b), oscillating fringes and secondary cracks. SEM-RE.

BAM-Gutachten Aktenzeichen: 20045220 Seite 37 von 52

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Figure 35: Details of the fracture surfaces P2-2: Region 4. crack initiation at HAZ of the interrupted laser weld
P2-2p. SEM-RE.

In contrast to the other regions, region 4 shows the crack initiation at the HAZ of weld
P2-2p. The microstructure of the fracture surface is influenced by the weld
microstructure, Figure 35.

3.2.3 Summary of the fracture mechanisms at P1 and P2

All features found on the analysed fracture surface are presented as fractographic
sketches together with the fracture mechanisms, Figure 37, Figure 38, Figure 39.

F,aktog,afische sk;zze Pl-1 j

� Swinging strips
W

�X
Combs

Rubbed areas .....__..

-
- - Outer contour of a fracture surfacee --=
Noticeable structures
Snap line with directiong ( ) .._
Crack start area

Vibration fracture

Violent fracture

Figure 37: Fractographic sketch Pl-1: Fatigue fracture with small amount of residual force fracture. [Symbol set
v0.58 of the Fractographic Online Database fra ktogra p h ie@bam.de]

BAM-Gutachten Aktenzeichen: 20045220 Seite 38 von 52

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Figure 38: Fractographic sketch P2-1 of region 1 from Figure 32: Vibratory fracture with very small amount of residual
violent fracture. Symbols see Fig. 3

Fig. 39: Fractographic sketch P2-2, region 3 from Fig. 35: Vibratory fracture with small amount of residual violent
fracture. Symbols see Fig. 37

All the fractures found and investigated are predominantly due to the failure mechanism fatigue
fracture Fig. 37, Fig. 38 and Fig. 39. The fatigue cracks started at the tang weld. the interrupted
pulsed laser welds as well as at machining marks. Figure 40. The cracks propagate from the
inside to the outside of the end plates, both on the upper P2 and the lower P1 plate,
Figure 40.

BAM-Gutachten Aktenzeichen: 20045220 Seite 39 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

Crack initiation and propagation BAM

Figure 40: Location of the cracks and fatigue fractures on the damaged parts P2-1, P2-2, P1-2 and
P1-1

3.3 Metallographic examination: material structure

In order to examine the material structure, the coating of any cracks and the weld seams,
damaged part P1 was prepared metallographically and the two ground planes were examined
optically.

3.3.1 Sampling Separation Preparation

Grinding orientation of the OuterPlate P1-1

Probe Pl-1 Trennschnitt

Figure 41: Section plan of the damaged part of the end plate P1-1 (OuterEndPlate)

BAM-Gutachten Aktenzeichen: 20045220 Seite 40 von 62

Sicherheit in Technik und Chemie
 BAM
Bundesanstalt für
Materialforschung
und -prüfung

The end plate P1-1 was separated with a thread saw at a point that ensured that the tang
weld could be examined (see Fig. 41). The separated specimen P-1-1 was then embedded in
such a way that the direction of sectioning is with view to d. Due to the missing cover plate,
two surfaces can be seen on the micrograph (see Fig. 41, top right), which are called a and p in
the following page due to their orientation in the end plate. The section was then prepared
metallographically for examination under the light microscope, for which a tilted Olympus GX71
reflected-light microscope was available. The first ground section did not yet show the
complete lower tang weld, so that the ground surface was ground and polished again.

3.3.2 Microstructure
In order to make the microstructure of the Ti-6 Al-4 V alloy visible, the ground section was
etched with a Kroll etch on sight (Fig. 43). A very fine line structure developed, corresponding
to a longitudinal section, with globular alpha and beta titanium grains.
ASTM F1472, which applies to the material of the damaged part, refers to the more detailed
standard [ISO 5832-3:2000-08 "Metallic materials for surgical implants"] for the
microstructure. In accordance with this requirement, the ground surfaces were examined and
the microstructure evaluated using the ETTC 2 microstructure series. Accordingly, the
microstructure meets the requirements.

3.3.3 Cracks
In section 2 (see figure 41, centre), one continuous crack and three incipient cracks are clearly
visible on side p in the unetched state (figure 42). At higher magnification, there is a little
corrosion in the middle of the continuous crack (Fig. 42, top left). This continuous crack is an
incipient crack running from p to a. In picture 43 (left side) you can see the cut of the crack,
through the marked ground plane. On side a of the section, no further cracks are visible except
for the weld fracture and a crack in the rest of the weld, Figure 49.

BAM-Gutachten Aktenzeichen: 20045220 Seite 41 von 62

Sicherheit in Technik und Chemie