MAUDE Adverse Event Report: AESCULAP AG ACTIV L SUP.PLATE SIZE XL 6°/SPIKES; IMPLANTS SPINAL MOTION

Model Number	SW891K
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results are provided, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was an issue with sw891k - activ l sup.Plate size xl 6°/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 xc reference (b)(4).Involved components: sw888k, sw965.
Event or Problem Description
No updates required.
Additional Manufacturer Narrative
Manufacturing site evaluation: 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 aig reference (b)(4).Involved components: sw888k; sw891k; sw891k; sw965.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

• Brand Name: ACTIV L SUP.PLATE SIZE XL 6°/SPIKES
• Common Device Name: IMPLANTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13236507
• Report Number: 2916714-2022-00001
• Device Sequence Number: 11823118
• Product Code: MJO
• UDI-Device Identifier: 04038653456765
• UDI-Public: 4038653456765
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2022
• Report Date (Section F): 01/12/2022

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 Expiration Date: 03/24/2025
• Device Model Number: SW891K
• Device Catalogue Number: SW891K
• Device Lot Number: 52604384
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2021
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 08/12/2022; 09/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SW888K.; SW965.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 01/12/2022