activL® SW982KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653425839), received between Dec 7, 2021 and Dec 29, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO AESCULAP AG THAT AN ACTIV L IMPLANT (PART # UNKNOWN) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2021. THE PHYSICIAN PLANNED TO REPLACE THE ACTIV L IMPLANT BY PERFORMING A 360 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE AND PEDICLE SCREWS. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVISION SURGERY WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: ((B)(4)); 9610612-2021-00797 ((B)(4)); 9610612-2021-00798 ((B)(4)).

  Patient problems: Failure of Implant

  MAUDE report 13112270 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO AESCULAP INC. THAT AN ACTIVE L IMPLANT (PART # UNKNOWN) WAS IMPLANTED DURING A PRIMARY PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PATIENT IS SCHEDULED TO UNDERGO A REVISION PROCEDURE ON (B)(6) 2021. THE PHYSICIAN PLANS TO REPLACE THE ACTIV L IMPLANT BY PERFORMING A 360 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE AND PEDICLE SCREWS. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 12955139 ↗