MAUDE Adverse Event Report: AESCULAP AG ACTIV L PE-INLAY 10MM; SPINE SURGERY

Model Number	SW966
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	12/13/2022
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 that there was an issue with sw966 - activ l pe-inlay 10mm.According to the complaint description, there was a reoperation and removal as patient has a retroperitoneal abscess at l4/5-l5/s1.The surgeon stated that the patient would be heading back to surgery very soon for an additional posterior construct to reinforce the anterior cages at l4/5 and l5/s1.A revision surgery was necessary.The adverse event is filed under aag reference 100032168 (400582802).Associated medwatch-reports: 400582800 (9610612-2022-00394) - sw990k, 400582801 (9610612-2022-00395) - sw991k, 400582802 (9610612-2022-00396) - sw966.
Additional Manufacturer Narrative
Additional information: b5 - updated description, b6 - tests, d4 - expiration date, g4 - 510(k) number, h4 - manufacture date, h6 - codes updated.Investigation results: aesculap ag did not receive a product for investigation.Therefore the investigation results are based on device history review.Batch history review: the device quality and manufacturing history records have 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 currently no further complaints with this lot at hand and no similar complaints.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.Conclusion/preventive measures: on basis of the available information as well as the investigation results a clear root cause conclusion cannot be drawn.There is no indication fo a material-, manufacturing- or design- related failure.In the event that the complaint sample will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.
Event or Problem Description
Update: per the surgeon, the patient is doing very well postoperatively.Certain cultures taken were positive for streptococcus pyogenes.Several sites were tested including the device once it was removed.It was noted that the patient may be having surgery again to reinforce the anterior cages at both levels.Associated medwatch-reports: 9610612-2022-00394 (internal aesculap ag ref.No.(b)(4) - sw990k).9610612-2022-00395 (internal aesculap ag ref.No.(b)(4) - sw991k).9610612-2022-00396 (internal aesculap ag ref.No.(b)(4) - sw966).

• Brand Name: ACTIV L PE-INLAY 10MM
• 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 gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16230493
• Report Number: 9610612-2022-00396
• Device Sequence Number: 17743841
• Product Code: MJO
• UDI-Device Identifier: 04038653430956
• UDI-Public: 4038653430956
• 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 Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 02/08/2026
• Device Model Number: SW966
• Device Catalogue Number: SW966
• Device Lot Number: 52666869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2022
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2021
• 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