activL® SW891KRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04038653456765), received between Jan 12, 2022 and Sep 27, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Migration” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 12, 2022Migration; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW891K - ACTIV L SUP.PLATE SIZE XL 6°/SPIKES. 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 (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00002 (400541664 - SW888K). 9610612-2022-00003 (400541665 - SW965). 9610612-2021-00814 (400541569 - SW891K). LINKED TO AAG REFERENCE XC (B)(4); SAME PATIENT. ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00133 (400556960 - SW891K). 9610612-2022-00134 (400556961 - SW965). 9610612-2022-00135 (400556959 - SW990K).

  Patient problems: Failure of Implant

  MAUDE report 15219372 ↗
• 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 MAY 26, 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 14777143 ↗
• InjuryJan 14, 2022Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW891K - ACTIV L SUP.PLATE SIZE XL 6°/SPIKES. 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 (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2022-00002 (400541664 - SW888K), 9610612-2022-00003 (400541665 - SW965), 9610612-2021-00814 (400541569 - SW891K).

  Patient problems: Failure of Implant

  MAUDE report 13260519 ↗
• InjuryJan 12, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW891K - ACTIV L SUP.PLATE SIZE XL 6°/SPIKES. 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 XC REFERENCE (B)(4). INVOLVED COMPONENTS: SW888K, SW965.

  Patient problems: Failure of Implant

  MAUDE report 13236507 ↗