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
Event or Problem Description
It was reported to aesculap inc.That an activ l pe-inlay 10mm (part# sw966) was implanted during a hybrid at l4/5 and fusion device l5/s1 procedure performed on (b)(6) 2022 according to the complainant, the patient underwent a reoperation and removal on (b)(6) 2022 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.As it was reported the patient had a retroperitoneal abscess at l4/5-l5/s1.The complaint device was returned to the manufacturer for evaluation.A revision surgery was necessary.The adverse event is filed under aag reference xc 100032168; cc 400582803.Associated medwatch reports: 400582801_2916714-2023-00022_mdr, 400582800_2916714-2023-00021_mdr.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for the available lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: ACTIV L PE-INLAY 10MM
• Common Device Name: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16230611
• Report Number: 2916714-2023-00023
• Device Sequence Number: 12510770
• Product Code: MJO
• UDI-Device Identifier: 04038653430956
• UDI-Public: 4038653430956
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024
• Report Date (Section F): 01/23/2023

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 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/25/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 10/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/23/2023