MAUDE Adverse Event Report: AESCULAP AG ACTIV L PE-INLAY 8.5MM; IMPLANTS SPINAL MOTION

Model Number SW965

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with sw965 - activ l pe-inlay 8.5mm.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 100029934.Associated medwatch-reports: 9610612-2022-00002 (400541664 - sw888k) 9610612-2021-00814 (400541569 - sw891k).

Manufacturer Narrative

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 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 PE-INLAY 8.5MM
• Type of Device: 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: 13231361
• MDR Text Key: 288880289
• Report Number: 9610612-2022-00003
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 04038653430949
• UDI-Public: 4038653430949
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SW965
• Device Catalogue Number: SW965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male