It was reported that there was an issue with sw888k - activ l inf.Plate s1 size xl 5°/spikes.The original implantation occurred on (b)(6) 2021 at l3/l4 and l4/l5 during a lumbar total disc replacement (tdr).According to the complaint description, a re-operation/removal of the devices due to post-operative events, including anterior and lateral migration.A revision surgery was necessary; a fusion was performed.The surgical site description was noted as "normal".Additional information was not provided.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2022-00003 (400541665 - sw965), 9610612-2021-00814 (400541569 - sw891k).
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Correction: see b5.Investigation: the explants were sent directly to an institute, third party evaluation, we received no devices for analysis or archiving.Because we received only 3 pictures, an investigation was not possible.The investigation by exponent noted no dimensional-deviation of the implants.A further investigation without the explants is not possible.Batch history review: the device quality and manufacturing history records (dhr) have a been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Due to the fact that no lot number was provided for the inlays, a review of the dhrs for the complained device was not possible.Explanation and rationale: the following causes are possible: - wrong system configuration selected by the user.- wrong implant size chosen by the user.- end plate formed too strong by the user.- design layout unsuitable.- inadequate patient behavior.Conclusion and root cause: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.
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