activL® SW996KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963143862), received between Aug 10, 2022 and Nov 4, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Migration; Migration

  ACCORDING TO THE COMPLAINANT AND ACTIVL DEVICE WAS IMPLANTED ON AN UNSPECIFIED DATE. REPORTEDLY THE PATIENT WAS SCHEDULED TO HAVE THE ABC 2 PLATE REMOVED ON (B)(6) 2024. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 20597683 ↗
• InjuryMay 3, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO AESCULAP INC. THAT AN ACTIV L INF.PLATE S1 SIZE L 5°/SPIKES (PART # SW996K) 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). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00078 AND 2916714-2024-00079.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19237142 ↗
• InjuryAug 10, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED TO AESCULAP INC., VIA THE ANNUAL ACTIVL ENHANCED SAFETY SURVEILLANCE STUDY (ESS) COVERING A REPORTING PERIOD FROM 01FEB2021 TO 31JAN2022, THAT AN UNKNOWN ACTIV L DEVICE WAS IMPLANTED. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED A POSTOPERATIVE "SENSORY NEUROLOGICAL SAFETY EVENT." THE INITIAL SURGERY OCCURRED ON AN UNSPECIFED DATE. THE PATIENT HAD BEEN TREATED AT THE L5-S1 LEVEL WITH THE SPIKE ENDPLATE. THE PATIENT DEVELOPED BILATERAL PARS FRACTURES 10 MONTHS AFTER HAVING THE ARTHROPLASTY DEVICE IMPLANTED. A PERMANENT IMPAIRMENT OCCURRED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE, ALTHOUGH IT HAD BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AIC REFERENCE XC 100031157 / 400562858. ASSOCIATED MEDWATCH REPORTS: 2916714-2022-00077 (400562857 - AE-QAS-SP42) ; 2916714-2022-00079 (400562859 - AE-QAS-SP42).

  Patient problems: Pain

  MAUDE report 15201558 ↗