activL® SW991KRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04038653425891), received between Jun 22, 2022 and May 3, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN ACTIV L SUP.PLATE SIZE L 6°/SPIKES (PART # SW991K) WAS IMPLANTED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2024. REPORTEDLY THE IMPLANTS WERE REMOVED DUE TO THE PATIENT'S COMPLAINTS OF PAIN. THERE WAS NO DEFECTS FOUND WITH THE IMPLANTS UPON REMOVAL. THE SURGEON FELT THAT THE PATIENT'S SYMPTOMS WERE PSYCHOLOGICAL IN NATURE AS SUCH THE COMPLAINT WAS NOT REPORTED NOR WAS AN EXPLANT KIT REQUESTED. THE SURGEON SENT THE DEVICE TO PATHOLOGY AND NO GROWTH WAS FOUND TO INDICATE AN INFECTION. THE DEVICES ARE WITH THE HOSPITAL AND NOT AVAILABLE FOR EVALUATION. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4) (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00078 2916714-2024-00080.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19237144 ↗
• 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 16230492 ↗
• InjuryJan 23, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO AESCULAP INC. THAT AN ACTIV L SUP.PLATE SIZE L 6°/SPIKES (PART# SW991K) 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 (B)(4); CC (B)(4). ASSOCIATED MEDWATCH REPORTS: 400582800_2916714-2023-00021_MDR. 400582802_2916714-2023-00023_MDR.

  Patient problems: Peritonitis

  MAUDE report 16230490 ↗
• InjuryJun 22, 2022Migration; Migration

  IT WAS REPORTED TO AESCULAP INC. THAT AN ACTIV L IMPLANT SYSTEM (PART # UNKNOWN) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE DEVICE MIGRATED ONE MONTH POST SURGERY. REPORTEDLY, THE PATIENT HAD A MULTI-LEVEL LUMBAR ARTHROPLASTY FROM TWO PRIOR SURGERIES. THE PATIENT HAD A COMPETITIVE DISC REPLACEMENT AT L5/S1 PERFORMED ON AN UNKNOWN DATE. DURING A SECONDARY SURGERY, PERFORMED IN (B)(6) 2022, THE ACTIV L DEVICES WERE IMPLANTED AT LEVELS L4/L5 AND AT L3/L4. THE TOP LEVEL, L3/L4, THE UPPERMOST OF THE THREE (3) IMPLANTS, MIGRATED ANTERIORLY, WHICH REQUIRED EXPLANTATION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. THE ACTIV L DEVICE WAS REMOVED WITHOUT INCIDENT DURING THE LATERAL REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 2916714-2022-00065 (400556959 - AE-QAS-SP42) AND 2916714-2022-00066 (400556960 - AE-QAS-SP42)

  Patient problems: Failure of Implant

  MAUDE report 14777140 ↗
• InjuryJun 22, 2022Migration; Migration

  IT WAS REPORTED TO AESCULAP INC. THAT AN ACTIV L IMPLANT SYSTEM (PART # UNKNOWN) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE DEVICE MIGRATED ONE (1) MONTH POST SURGERY. REPORTEDLY, THE PATIENT HAD A MULTI-LEVEL LUMBAR ARTHROPLASTY FROM TWO (2) PRIOR SURGERIES. THE PATIENT HAD A COMPETITIVE DISC REPLACEMENT AT L5/S1 PERFORMED ON AN UNKNOWN DATE. DURING A SECONDARY SURGERY, PERFORMED IN (B)(6) 2022, THE ACTIV L DEVICES WERE IMPLANTED AT LEVELS L4/L5 AND AT L3/L4. THE TOP LEVEL, L3/L4, THE UPPERMOST OF THE THREE (3) IMPLANTS, MIGRATED ANTERIORLY, WHICH REQUIRED EXPLANTATION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. THE ACTIV L DEVICE WAS REMOVED WITHOUT INCIDENT DURING THE LATERAL REVISION PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 2916714-2022-00065 ((B)(4) - AE-QAS-SP42). 2916714-2022-00066 ((B)(4) - AE-QAS-SP42). 2916714-2022-00067 ((B)(4) - AE-QAS-SP42).

  Patient problems: Failure of Implant

  MAUDE report 14777138 ↗