Bundesanstalt für
Materialforschung
und -prüfung
I
l.
• 1
BFig. 42: Overview of end plate P1 side p of ground plane 2, unetched with one continuous crack and three
further incipient cracks
Schliffebene 2.
Sicht Richtung d
Fig. 43: Overview of end plate P1 of side p of ground plane 2. etched with Kroll; yellow frame corresponds to Fig.
45
3.3.4 Coating
According to the technical drawing [Appendix 34], the coating should have a thickness of
0.1075 mm to 0.2532 mm. Furthermore, in [Annex 5, Risk Management, page 34] there is a
reference to the possible failure mode of the coating due to delamination. The possible
causes are: contaminated surface before coating; improper TPS coating process; and/or
overstressing after processing. The delamination of the coating can be clearly observed in
the SEM, Figure 44.
Since it is also visible at a surface location without firmly attached bone remnants, the
delamination probably does not originate from explantation.
Tear
Crack/
Delamination/
Coating Defect
Figure 44: Coating defect. PH, stereomicroscope (top) and SEM (bottom).
Scanning by µCT showed an uneven distribution of the coating, in some places with very small
thickness (up to 0.048 mm), Figure 45, which is not within the range of the above nominal
value. The cross-section through the end plate P1 also shows the round raw particles, Fig. 46,
which were not melted during the coating process, and the insufficient bond between the
coating and the metal substrate, Fig. 46.
Coating:
0,048 mm-0,190 mm
Coating with
• non-melted
particles Q
Tears ....,.
Insufficient
connection to the
basic material -+
Corrosion products
between layer and
Base material ....,.
Outline
2
-:....c.... . I
Fig. 45: Section of Fig. 43 of side p of ground plane 2, etched with Kroll, layer structure
On the comparative part VP7, the Ti coating is also too thin and irregular in places, Fig. 59,
and shows individual larger pores and cracks.
3.3.5 Welds
The outer end plates P1 and P2 are joined to the inner end plates T1 and T2 by two laser
welds each: in the centre the circular post weid (post weid), see Fig. 5, and on the outside
the interrupted pulsed laser weld (seam weid), Fig. 53, Fig. 55 and Fig. 56, i.e. a total of 5
weld sections each.
On the right side of picture 43, in the overview picture of the ground surface of side p, you
can see the tenon weld and, on the left side below, the interrupted pulsed laser weld and its
heat-affected zone (HAZ). The oblique position of the section means that the interrupted
pulsed laser weld (seam weid) can only be seen once. Figure 53.
Stud weld
Figure 47: Overview of side p of ground plane 2, etched with Kroll, tenon weld (top) and large radius hole
reveal (bottom).
The specification for the welding depth from [Appendix 37 Manufactruing Process
lnstruction MPI 0077 Rev.3 of 20.11.2008 Section 6.37 page 8 of 12] (75% of the adjacent
surfaces of approx. reconstructed 284 µm) was not achieved with approx. 165 µm, Figure
48.
Stud weld
Figure 48: Pulsed laser weld on side p of ground plane 2, etched with Kroll: Required welding depth (75% of the
adjacent surfaces) not achieved
The other ground side a shows only remnants of the tang weld, Fig. 49. Traces of massive
deformation can be seen on the "hump" on the right of Fig. 49.
d
Platte Pl-1-1, Seite a
mm
Fig. 49: Overview of side a of ground plane 2: remnants of the central tenon weld on the left of the picture,
plastic deformations on the cusp on the right of the picture, etched
Details of the weld remnants side a, picture SO, show smaller weld width than on side p,
picture 47.
Plate Pl-1-1; superimposed tenon weld of side a with Stud weld width
mirrored side p Side a Side p
Fig. 57: Superimposed tang welds of sides a and p; ground plane 2, etched
If one compares the geometry and position of the tenon weld of the damaged part P7 with
that of the comparison part VP1, Fig. 52, it becomes clear that the welding depth on the
comparison part is higher than that on the damaged part, but both are less than the 75%
requirement. Due to the consequential damage of the damaged parts, it is NOT possible to
determine whether there was ever a chamfer in the hole reveal according to the drawing,
Figure 52.
OuterPlate Pl-1-1
superimposed tang
welds compared with
superimposed, CT
image of reference part
VPl
Fig. 52: Superimposed tenon welds of sides a and p of end plate P1, as well as the µCT image of the comparison
part. The inner cover plate VT of the reference part V can be seen at the bottom.
On the damaged part, 49 weld spots were counted at P1 on the tenon weld, cf. upper photo
in Fig. 23. As these overlap at the beginning of the weld, the requirement SO ... 51 spots is
considered fulfilled. The number of weld spots could not be determined on the fragments
P2, Fig. 15, and T1, Fig. 17, due to the heavy rubbing.
If the ground plane 2 is transferred to the overview of the inner side of the end plate P1-1,
it becomes clear that it is the rubbed pulsed laser weld p, on the right in Figure 53.
Fig. 53: Contact damage on the 3 "cusps"; outer interrupted pulsed laser weld (four sections) in plan view on the
left and in ground plane 2 (etched) on the right
The 4 interrupted pulsed laser welds on the damaged part Pl were each examined with
regard to the number of visible laser welding pulses, Fig. 54. With 77 lateral (d + s), their
number is below the nominal value d-s 74 - 78 and with 75 each a + p below the nominal
value a-p 18 - 24. The executed welds on the damaged part P1 do not meet the specification,
Fig. 54.
Fig. 54: Interrupted pulsed laser weld of the P1 in the stereo microscope and SEM; counting of the visible laser
welding pulses; comparison with the nominal values, fusion due to incorrectly aligned laser beam (far left and far
right in the image)
a?
Also on the fragments of P2, fewer welding pulses can be counted laterally in the
stereomicroscope than specified, Fig. 55. Due to the strong secondary abrasion or missing
fragments, the number of welding pulses of the outer laser welds can no longer be
counted in the SEM, Fig. 56.
.;,
Photo 57: Detail of photo 56 right photo, photo 58: Detail of photo 57 melted spatter; in the upper part of the
photo you can see the weld seam.
For this purpose, the reference part was examined for comparable deposits, but no weld
spatter could be detected on this part, Figure 64, Figure 65. These spatters are therefore
evaluated here as manufacturing defects of the damaged part.
3.3.S.4 Stud welds on reference part V
On the reference part, 49 weld spots (pulses) were counted on each of the two tenon welds,
Figure S. Since these overlap at the beginning of the weld, the requirement SO ... 51 spots
from [Annex 37, MPI 0077, Page 12 of 12] is considered fulfilled.
The reference part was examined non-destructively by micro-computed tomography (µCT).
During the inspection, a pore with a diameter of approx. 0.03 mm was detected in the tang
weld. According to DIN EN ISO 13919-1:2020-03 - [Electron and laser beam welded joints -
Requirements and recommendations for evaluation groups," Beuth-Verlag, DIN Standards
Committee on Welding and Allied Processes (NAS), Berlin, 2020-03] evaluation group B, the
maximum dimension for void/pore is d:,; 0.3 s or 2 mm, whichever is smaller, and the area
fraction of the pore is f:,; 2 %. This results in a permissible dimension of Pmax permissible:,;
0.14 mm for the permissible expansion of the pore detected here, given the existing sheet
thickness of approx. 0.45 mm. Accordingly, the dimensions of this pore are permissible
here.
In addition, during the CT tests, as with the metallographic examinations on the damaged
part (see 3.3.5.1), the welding depth was checked on the comparison part. For this purpose,
several sections were projected through the joining points of the top plate VT1 / lower end
plate VP1 and the stud / upper end plate VP2. Figure 59 to Figure 63.
In picture 59 the projected cut is approximately at the level of the sheet edge of the lower
end plate VP1. In the top left partial image, the joint gap between the trunnion and the
lower end plate can be seen in the centre. Here the joint gap appears larger than in the
following cut, but this is due to the fact that the cut is on the chamfer, see Fig. 59 and Fig.
60.
°
Cut 0
Fig. 59: CT test on the reference part - lower end plate (VP1).
The section at 0 degrees shown in Fig. 60 shows a first connection (material connection
through the welding process) between the stud and the lower end plate VP1. As can still be
seen in Fig. 60, there is still no complete connection (360°), as the open joint gap is still
partially visible (between approx. 0° and 180°, lower part).
Figure 60: CT test on the reference part - lower end plate (VP1)
The joint of the section in picture 50 ("First connection") was measured and then evaluated.
The individual areas of the joint and the corresponding values are recorded in the
enlargement. Figure 51.
Welding depth-IST:
0,15 mm
(connected
contact surface)
Magnification - cut 0°
VT2
Figure 52: CT test on the reference part - upper end plate VP2 with cover plate VT2
Furthermore, a larger deviation between the ACTUAL weld penetration depth of the laser
stud weld compared to the specified nominal weld penetration depth is clearly visible here.
Due to the non-achievement of the target specification for the minimum penetration depth of
0.75 % (here approx. 0.25 mm), there is a manufacturing defect for this joint at the lower end
plate VP1/VT1 of the comparison part, as with the damaged part (see para. 3.3.5.1, Fig. 48).
In contrast, the two representations of the projected sections from the joining point of the
upper end plate VP2 show a significantly better connection to the tenon of the cover plate VT2
by the pulsed laser process, Figure 52 and Figure 53.
Figure 52 illustrates that here a partial connection of the individual parts to be joined already
took place at the chamfer end.
In the next section, where a complete connection (350°) was first realised, a welding depth of
approx. 0.27 mm was determined. Thus, there is no manufacturing defect in the execution of
the pulsed laser weld at the checked joining point of the upper end plate of the comparison
part VP2, Figure 52.
VT2
Figure 53: Results of the CT test on the reference part - upper end plate VP2
• ' 7, -=-
Laserpunkte
a+Q. soll= 18-24
9±� soll= 14-18
Figure 54: Interrupted pulsed laser weld of VP1 under the stereo microscope.
The measured values shown demonstrate, taking into account the measurement tolerances, that the chemical
composition of the tested samples from the intervertebral disc prosthesis complies with the specifications of the
standard [ASTM F 1472-2008-01-Forged Alloy Ti Al V 6 4 for Implants Table 1] within the analytical tolerance
TABLE 2.
Vickers hardness measurement HVl according to DIN EN ISO 6507 on the Pl-1-1 side a
341 340
- 334
3
3.J
[.t--
_ _
_/_•� - �32�8---.,,.----+/
- _ _ ____--t_ Mittelwert= 328 HVl
_____
322 SHVl= cclO HVl
-
J: �/ 3;5
Literaturwert ==311 HV
310
Figure 56: Hardness measurement HV1 according to DIN EN ISO 5507 on the ground section of damaged part
Pl-1-1, side a with the DuraScan G5
No conversion values are given in DIN EN ISO 18255 for this material. Therefore, literature
values were used to estimate the tensile strength of the implant plate. According to the
literature [Titanium and titanium alloys], strength values for a Ti-5Al-4V alloy of 900 to
7200 N/mm2 and the associated Vickers hardness of 300 to 400 HV are possible.
In the literature [Mat.-wiss. u. Werkstofftech. 34, 529-541 (2003)] the Vickers hardness for
this material was determined to be approx. 330 HV1. The hardness of approx. 330 HV1
determined for the damaged part was estimated at approx. 990 N/mm2. The minimum
tensile strength of 930 N/mm2 required by the standard is thus fulfilled by the damaged
part.
l<ap. 4.3.
The l<onstruction of the M6-C is designed in such a way that, for the largest implant (size !arge), at °
6 lateral flexion and 7.5° flexion/extension at the corners/humps a direct l<contact
between the upper and lower endplates [Test report V0040P = Appendix 17 Page
33 of 35). If these angles are exceeded after implantation into the body
If these angles are exceeded after implantation in the body, metallic contact would occur between the two end
plates and tensile stresses would act on the weld seams.
4.3 Construction
Existing implants from different manufacturers have very different design features. Standardised product-
oriented legal or normative design
We are not aware of any standardised product-oriented legal or normative construction specifications.
Therefore, a construction error cannot be proven. Possible design improvements have been described by the
manufacturer
Spinall<inetics in [Annex 4, design history file].
The manufacturer SpinalKinetics planned, carried out and evaluated a series of static and
dynamic tests derived from the test standard [ASTM F2423 "Standard Guide for the Functional
and Kinematic Wear Assessment of Total Disc Prosthesis"]. These were initially carried out on
7 mm implants, and later also on 6 mm implants, see Appendix 4 [Design History File DHF
0003]. These were also analysed in detail by Prof. Bader, Annex 3 and here in the expert
opinion chapter 2.3.3. Extensive risk analyses and assessments were also carried out.
In accordance with the order, cf. chapter 4.1, a possible design-related undersizing of the M6-C
disc endoprosthesis was not investigated.
a. The penetration depth of the lower journal seam P1/T1 is significantly less than the 75% of the interface
area required in the production specification MPI 0077, chapter 3.3.5.1, figure 48. The upper journal seam
P2/T2 is not present.
Abteilung 9. Komponentensicherheit
�ur
im Auftrag im Auftrag
�RiJ:> �
Dipl.-Ing. M. Eli
Interdisziplinäre Schadensanalyse Interdisziplinäre Schadensanalyse
Fachbereich 5.3
Polymere Verbundwerkstoffe
im Auftrag
j_Js_
Dipl.-Ing. (FH) L. Buchta
Interdisziplinäre Schadensanalyse
We assure that the expert opinion has been prepared to the best of our knowledge and belief,
impartially and free from bias. BAM reserves the right to make subsequent changes, additions
and, if necessary, revocation of the expert opinion for important reasons (e.g. due to
significant new findings).