activL® SW966Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653430956), received between Jan 23, 2023 and Jan 23, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  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.

  Patient problems: Peritonitis

  MAUDE report 16230611 ↗
• InjuryJan 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  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).

  Patient problems: Peritonitis

  MAUDE report 16230493 ↗