MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE S1 SIZE XL 5°/SPIKES; IMPLANTS SPINAL MOTION

Model Number	SW888K
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
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).
Additional Manufacturer Narrative
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.
Event or Problem Description
The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2022-00002 (400541664 - sw888k).9610612-2022-00003 (400541665 - sw965).9610612-2021-00814 (400541569 - sw891k).9610612-2022-00245 (400564529 - sw891k).Linked to aag reference (b)(4); same patient.Associated medwatch-reports: 9610612-2022-00133 (400556960 - sw891k).9610612-2022-00134 (400556961 - sw965).9610612-2022-00135 (400556959 - sw990k).

• Brand Name: ACTIV L INF.PLATE S1 SIZE XL 5°/SPIKES
• Common Device Name: IMPLANTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13231137
• Report Number: 9610612-2022-00002
• Device Sequence Number: 17213501
• Product Code: MJO
• UDI-Device Identifier: 04046963143817
• UDI-Public: 4046963143817
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P120024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SW888K
• Device Catalogue Number: SW888K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male