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

Model Number	SW965
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap aag that an activ l implant system (part # unknown) was implanted during a procedure performed in (b)(6) 2022.According to the complainant, the device migrated one (1) month post surgery.Reportedly, the patient had a multi-level lumbar arthroplasty from two (2) prior surgeries.The patient had a competitive disc replacement at l5/s1 performed on an unknown date.During a secondary surgery, performed in april 2022, the activ l devices were implanted at levels l4/l5 and at l3/l4.The top level, l3/l4, the uppermost of the three (3) implants, migrated anteriorly, which required explantation.The patient underwent a revision surgery on (b)(6) 2022.The complaint device has not yet been returned to the manufacturer for evaluation.A revision surgery was necessary.No patient complications were reported as a result of the revision surgery.The activ l device was removed without incident during the lateral revision procedure.That there was an issue with ae-qas-sp42 - collect.No.Qas spine anterior stabilis.The actual device is unknown.The adverse event is filed under aag reference 100030868.Associated medwatch-reports: 9610612-2022-00133 (400556960 - ae-qas-sp42), 9610612-2022-00135 (400556959 - ae-qas-sp42).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
Correction: product code: sw965; product descrption: activ l pe-inlay 8.5mm.Associated medwatch-reports: 9610612-2022-00133 ((b)(6) - sw891k); 9610612-2022-00134 ((b)(6) - sw965); 9610612-2022-00135 ((b)(6) - sw965).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: 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.Based upon the investigations results a capa is not necessary.
Event or Problem Description
(b)(4).Associated medwatch-reports: 9610612-2022-00133 (400556960 - sw891k).9610612-2022-00134 (400556961 - sw965).9610612-2022-00135 (400556959 - sw965).Linked to aag reference: (b)(4); same patient.Associated medwatch-reports: 9610612-2022-00002 (400541664 - sw888k).9610612-2022-00003 (400541665 - sw965).9610612-2021-00814 (400541569 - sw891k).
Additional Manufacturer Narrative
Additional information: a - patient sex.B5 - linked ccs.B7 - relevant medical history.Implants from the same patient, reported separately, were sent to a third party for evaluation.Clinical details about the patient were made available.
Event or Problem Description
Update: one of the leading materials was updated to sw991k (aesculap ag reference no.(b)(4)).
Additional Manufacturer Narrative
Additional information: b5 - update on linked leading material.Implants had been sent to a third party for evaluation.Investigation results were updated by the manufacturer.Investigation: the investigation report of exponent noticed no dimensional deviation of the pe inlay (sw965).Unfortunately the exponent- investigation report contains only the dimensional analysis of the pe- inlay (sw965) but no analysis of the two plates.The result of the exponent- analysis shows no deviation to the product specification.Because additionally now the batch numbers of the two plates were received, it was possible to check the device history records.Even here no hints were found for a nonconformity of the sw990k or the sw991k.A further investigation without the explants is not possible.Batch history review: the device quality and manufacturing history records have been checked for all leading device(s) lot numbers and the product found to be according to our specification valid at the time of production.There is one similar complaint against the same lot number for sw991k.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, revision surgery.Explanation and rationale: unfortunately the exponent investigation report contains only the dimensional analysis of the pe- inlay, but no analysis of the two plates.The result of the exponent analysis shows no deviation to the product specification.Because now the batch numbers of the two plates were available, it was possible to check the device history records.Even here there were found no hints for a nonconformity of the two plates.Because there are no products, and only minor information available, a definitive root cause analysis is not possible.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 behaviour because the device history records are without any deviation, a material defect or manufacturing failure can be excluded.Conclusion/preventive measures: the root cause cannot be finally concluded.See explanation and rationale above.Based upon investigation results, a capa is not necessary.

• Brand Name: ACTIV L PE-INLAY 8.5MM
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 14777146
• Report Number: 9610612-2022-00134
• Device Sequence Number: 4562687
• Product Code: MJO
• UDI-Device Identifier: 04038653430949
• UDI-Public: 4038653430949
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/23/2024
• 2 Devices were Involved in the Event: 1 2

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: SW965
• Device Catalogue Number: SW965
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 07/15/2022; 01/30/2024
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 07/19/2022; 08/17/2022; 02/23/2024
• 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