activL® SW986KRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046963143848), received between Jul 7, 2020 and Apr 20, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH AN ACTIV L INFERIOR PLATE. ACCORDING TO THE COMPLAINT DESCRIPTION,A POSTOPERATIVE REVISION OCCURRED DUE TO SUBSIDENCE. THE ORIGINAL IMPLANTATION WAS ON (B)(6) 2020. ADDITIONAL INFORMATION HAS BEEN REQUESTED.. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER XC REFERENCE (B)(4). ASSOCIATED COMPONENTS: UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11693772 ↗
• InjuryApr 19, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH SW986K-ACTIV L INF.PLATE S1 SIZE M 5°/SPIKES. ACCORDING TO THE COMPLAINT DESCRIPTION,A POSTOPERATIVE REVISION OCCURRED DUE TO SUBSIDENCE. THE ORIGINAL IMPLANTATION WAS ON (B)(6) 2020. ADDITIONAL INFORMATION WAS NOT PROVIDED.. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED COMPONENTS: UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11686365 ↗
• InjuryAug 7, 2020Migration

  NO UPDATES.

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

  MAUDE report 10380822 ↗
• 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 10266556 ↗
• 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 INF.PLATE S1 SIZE M 5°/SPIKES. 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 IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00286 ((B)(4)/ SW965). 9610612-2020-00287 ((B)(4) / SW981K).

  Patient problems: Insufficient Information; Joint Disorder; Pain

  MAUDE report 10240971 ↗