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

Model Number SW980K

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event 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).

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 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
• Type of Device: 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
• MDR Text Key: 282928117
• Report Number: 9610612-2021-00798
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 04038653425815
• UDI-Public: 4038653425815
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2020
• 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