coflex Mallet UAT20100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260148890130), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE MANUFACTURER WAS MADE AWARE OF AN INSTRUMENT MALFUNCTION ON 6/27/2023. IT WAS REPORTED THAT THE HEAD OF A SYSTEM MALLET FRACTURED FROM THE HANDLE OF AN INSTRUMENT WHILE BEING USED DURING A SURGICAL PROCEDURE. THERE WERE NO KNOWN PATIENT COMPLICATIONS OR DELAY IN TREATMENT, AN ALTERNATE AVAILABLE MALLET FROM THE SURGICAL FACILITY WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. EMAIL INQUIRIES WERE SENT TO THE COMPLAINANT FOR ADDITIONAL COMPLAINT INCIDENT INFORMATION AND RETURN OF THE COMPLAINT INSTRUMENT, WHICH WERE UNSUCCESSFUL. AN RMA NUMBER WAS ISSUED FOR RETURN OF THE COMPLAINT INSTRUMENT, WHICH AS OF 7/26/2023 HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR ASSESSMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17410015 ↗