activL® SW965Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04038653430949), received between Jul 7, 2020 and May 3, 2024 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (6 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 11 most recent of 11 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 PE-INLAY 8.5MM (PART # SW965) 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: 2916714-2024-00079 AND 2916714-2024-00080.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19237143 ↗
• InjuryAug 10, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED TO AESCULAP INC., VIA THE ANNUAL ACTIVL ENHANCED SAFETY SURVEILLANCE STUDY (ESS) COVERING A REPORTING PERIOD FROM (B)(6) 2021 TO (B)(6) 2022, 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 UNSPECIFIED 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 (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2022-00077 ((B)(4) - AE-QAS-SP42), 2916714-2022-00078 ((B)(4) - AE-QAS-SP42), ((B)(4) - AE-QAS-SP42).

  Patient problems: Pain

  MAUDE report 15201503 ↗
• InjuryJun 22, 2022Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED TO AESCULAP AAG 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 APRIL 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.THAT THERE WAS AN ISSUE WITH AE-QAS-SP42 - COLLECT.NO.QAS SPINE ANTERIOR STABILIS.. THE ACTUAL DEVICE IS UNKNOWN. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE 100030868. ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00133 (400556960 - AE-QA

  Patient problems: Failure of Implant

  MAUDE report 14777146 ↗
• InjuryJan 11, 2022Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW965 - ACTIV L PE-INLAY 8.5MM. THE ORIGINAL IMPLANTATION OCCURRED ON (B)(6) 2021 AT L3/L4 AND L4/L5 DURING A LUMBAR TOTAL DISC REPLACEMENT (TDR). ACCORDING TO THE COMPLAINT DESCRIPTION, A RE-OPERATION/REMOVAL OF THE DEVICES DUE TO POST-OPERATIVE EVENTS, INCLUDING ANTERIOR AND LATERAL MIGRATION. A REVISION SURGERY WAS NECESSARY; A FUSION WAS PERFORMED. THE SURGICAL SITE DESCRIPTION WAS NOTED AS "NORMAL". ADDITIONAL INFORMATION WAS NOT PROVIDED. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE 100029934. ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00002 (400541664 - SW888K) 9610612-2021-00814 (400541569 - SW891K).

  Patient problems: Failure of Implant

  MAUDE report 13231361 ↗
• InjuryDec 29, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ASSOCIATED MEDWATCH REPORTS: 9610612-2021-00784 ((B)(6) - SW982K). 9610612-2021-00798 ((B)(6) - SW980K). 9610612-2021-00797 ((B)(6) - SW965).

  Patient problems: Failure of Implant

  MAUDE report 13112276 ↗
• MalfunctionMay 11, 2021Product Quality Problem; Product Quality Problem

  INVESTIGATION COMPLETE.

  Patient problems: Failure of Implant

  MAUDE report 11807603 ↗
• InjuryJan 7, 2021Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE ACTIV L IMPLANT. THE ACTIVL IMPLANT MIGRATED 4 MONTHS AFTER SURGERY. ORIGINAL SURGERY WAS ON (B)(6) 2020; THE PROCEDURE WAS A TOTAL DISC REPLACEMENT (TDR). SOMETIME LATER, THE PATIENT WAS ON VACATION AND DID "SOMETHING IN OCEAN". . A REVISION SURGERY WAS NECESSARY. IMPLANT WAS REMOVED AND TREATMENT WAS FUSION ON (B)(6) 2020 ADDITIONAL INFORMATION WAS NOT PROVIDED. THE OPERATIVE REPORT WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER XC REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 2916714-2021-00001, 2916714-2021-00003.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131106 ↗
• InjuryAug 7, 2020Migration

  NO UPDATES.

  Patient problems: Failure of Implant; Inadequate Osseointegration; No Code Available

  MAUDE report 10380836 ↗
• InjuryAug 7, 2020Migration; Migration

  NO UPDATES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10380788 ↗
• InjuryJul 13, 2020Migration

  NO UPDATES. ASSOCIATED MEDWATCH-REPORTS: 2916714-2020-00235, 2916714-2020-00244, 2916714-2020-00245.

  Patient problems: Failure of Implant; Pain

  MAUDE report 10266519 ↗
• InjuryJul 7, 2020Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT ACTIV L PE-INLAY 8.5MM. SPECIFICALLY, IT WAS REPORTED THAT THERE WAS AN ANTERIOR MIGRATION OF IMPLANTS 6 MONTHS POST OPERATION. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4) ((B)(4)). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00287 (400477177 / SW981K). 9610612-2020-00288 (400477178 / SW986K).

  Patient problems: Insufficient Information; Joint Disorder; Pain

  MAUDE report 10240973 ↗