MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE SIZE M 0°/SPIKES; SPINE SURGERY

Model Number	SW980K
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
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
It was reported to aesculap ag that an activ l implant (part # unknown) was implanted during a primary procedure performed on an unknown date.According to the complainant, the patient was scheduled to undergo a revision procedure on (b)(6) 2021.The physician planned to replace the activ l implant by performing a 360 anterior lumbar interbody fusion (alif) procedure and pedicle screws.The complaint device has not yet been returned to the manufacturer for evaluation.A revision surgery was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00784 (400538175 - ae-qas-sp42), 9610612-2021-00797 (400539747 - ae-qas-sp42).
Additional Manufacturer Narrative
Additional information/correction: b5 - leading materials updated for associated medwatch reports.D1, 2 & 4 - leading material updated.G4 - 510k.H4 - production date.H6 - codes updated.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: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: the following causes are possible: - wrong system configuration selected.- wrong implant size chosen' - end plate formed too strong.- design layout unsuitable.- inadequate patient behavior.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
Associated medwatch reports: 9610612-2021-00784 (b)(6) - sw982k).9610612-2021-00798 ((b)(6) - sw980k).9610612-2021-00797 ((b)(6) - sw965).

• Brand Name: ACTIV L INF.PLATE SIZE M 0°/SPIKES
• Common Device Name: SPINE SURGERY
• 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: 13112264
• Report Number: 9610612-2021-00798
• Device Sequence Number: 4589737
• Product Code: MJO
• UDI-Device Identifier: 04038653425815
• UDI-Public: 4038653425815
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022
• 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 Expiration Date: 05/05/2025
• Device Model Number: SW980K
• Device Catalogue Number: SW980K
• Device Lot Number: 52610701
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2020
• 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: Unknown