activLRecalls & reported problems across all models

We found 16 models of activL by Aesculap AG in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2020 and Nov 4, 2024 — classified as 51 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported activL problems

activL models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• activL® SW965

  PROSTHESIS, INTERVERTEBRAL DISC
  11 reports
• activL® SW891K

  PROSTHESIS, INTERVERTEBRAL DISC
  10 reports
• activL® SW991K

  PROSTHESIS, INTERVERTEBRAL DISC
  5 reports
• activL® SW986K

  PROSTHESIS, INTERVERTEBRAL DISC
  5 reports
• activL® FW961R

  Manual instruments designed for use with total disc replacement devices
  4 reports
• activL® SW990K

  PROSTHESIS, INTERVERTEBRAL DISC
  4 reports
• activL® SW981K

  PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• activL® SW996K

  PROSTHESIS, INTERVERTEBRAL DISC
  3 reports
• activL® SW980K

  PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• activL® SW982K

  PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• activL® SW966

  PROSTHESIS, INTERVERTEBRAL DISC
  2 reports
• activL® FW965R

  Manual instruments designed for use with total disc replacement devices
  2 reports
• activL® SW970K

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report
• activL® SW972K

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report
• activL® SW992K

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report
• activL® SW888K

  PROSTHESIS, INTERVERTEBRAL DISC
  1 report

Recent activL adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE ACTIVL SPINAL IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, IMPLANTATION OF AN UNKNOWN ACTIVL DEVICE (THREE COMPONENTS) WAS PERFORMED AT L5-S1 LEVEL. THE PATIENT EXPERIENCED A SUSPECTED ANTERIOR MIGRATION OF DEVICE POSTOPERATIVELY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). 2916714-2024-00140 (AIC REFERENCE NO. (B)(4) ), 2916714-2024-00141 (AIC REFERENCE NO. (B)(4) ), 2916714-2024-00142 (AIC REFERENCE NO. (B)(4) ).

  Patient problems: Failure of Implant

  MAUDE report 20327986 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE ACTIVL SPINAL IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, IMPLANTATION OF AN UNKNOWN ACTIVL DEVICE (THREE COMPONENTS) WAS PERFORMED AT L5-S1 LEVEL. THE PATIENT EXPERIENCED A SUSPECTED ANTERIOR MIGRATION OF DEVICE POSTOPERATIVELY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). 2916714-2024-00140 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00141 (AIC REFERENCE NO. (B)(4)), 2916714-2024-00142 (AIC REFERENCE NO. (B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 20327887 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE ACTIVL SPINAL IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, IMPLANTATION OF AN UNKNOWN ACTIVL DEVICE (THREE COMPONENTS) WAS PERFORMED AT L5-S1 LEVEL. THE PATIENT EXPERIENCED A SUSPECTED ANTERIOR MIGRATION OF DEVICE POSTOPERATIVELY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). 2916714-2024-00140 (AIC REFERENCE NO. (B)(4) ), 2916714-2024-00141 (AIC REFERENCE NO. (B)(4) ), 2916714-2024-00142 (AIC REFERENCE NO. (B)(4) ).

  Patient problems: Failure of Implant

  MAUDE report 20327886 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE ACTIVL SPINAL IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, IMPLANTATION OF AN UNKNOWN ACTIVL DEVICE (THREE COMPONENTS) WAS PERFORMED AT L5-S1 LEVEL. THE PATIENT EXPERIENCED A SUSPECTED ANTERIOR MIGRATION OF DEVICE POSTOPERATIVELY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00138 (AESCULAP REFERENCE: (B)(4). 2916714-2024-00139 (AESCULAP REFERENCE: (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 20327529 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE ACTIVL SPINAL IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, IMPLANTATION OF AN UNKNOWN ACTIVL DEVICE (THREE COMPONENTS) WAS PERFORMED AT L5-S1 LEVEL. THE PATIENT EXPERIENCED A SUSPECTED ANTERIOR MIGRATION OF DEVICE POSTOPERATIVELY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00137 (AESCULAP REFERENCE (B)(4) ). 2916714-2024-00139 (AESCULAP REFERENCE (B)(4) ).

  Patient problems: Failure of Implant

  MAUDE report 20327239 ↗
• InjurySep 27, 2024Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A COMPONENT OF THE ACTIVL SPINAL IMPLANT SYSTEM. ACCORDING TO THE COMPLAINT DESCRIPTION, IMPLANTATION OF AN UNKNOWN ACTIVL DEVICE (THREE COMPONENTS) WAS PERFORMED AT L5-S1 LEVEL. THE PATIENT EXPERIENCED A SUSPECTED ANTERIOR MIGRATION OF DEVICE POSTOPERATIVELY. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). ASSOCIATED MEDWATCH REPORTS: 2916714-2024-00137 (AESCULAP REFERENCE (B)(4). 2916714-2024-00138 (AESCULAP REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 20326084 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 16230498 ↗
• 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 ↗
• 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 INF.PLATE SIZE L 0°/SPIKES (PART# SW990K) 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 DECEMBER 27 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 400582800. ASSOCIATED MEDWATCH REPORTS: 400582801_2916714-2023-00022_MDR, 400582802_2916714-2023-00023_MDR.

  Patient problems: Peritonitis

  MAUDE report 16230491 ↗

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