activL® SW980KRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653425815), received between Nov 7, 2021 and Dec 29, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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

  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 13112264 ↗
• MalfunctionNov 7, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT AN ACTIV L INF.PLATE SIZE M 0°/SPIKES (PART # SW980K) WAS TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, AFTER OPENING THE IMPLANT, THE SURGEON OBSERVED VERY POOR MACHINING AS WELL AS A VERY SMALL PIECE OF MATERIAL ON THE INLAY SURFACE. THE IMPLANT WAS EXCHANGED FOR ANOTHER AND THEN THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760853 ↗