CONMED 00509322600Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854004258), received between May 13, 2022 and May 13, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionMay 13, 2022Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 00509322600, 3.0MM ROUND BUR, CARBIDE, 5EA WAS BEING USED DURING A VERTEBRAL ARCH FORMATION PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT ¿THE CUSTOMER ALLEGED THAT THE BUR BROKE DURING USE. THERE WERE NO DEBRIS IN THE PATIENT¿S BODY.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE FRAGMENTED WHILE IN THE STERILE FIELD AND THE FRAGMENT FELL INTO THE SURGICAL SITE. THE FRAGMENT WAS RETRIEVED FROM THE SURGICAL SITE USING FORCEPS. AN ALTERNATE BACKUP BUR DEVICE WAS USED TO COMPLETE THE SURGERY AND THERE WAS REPORT OF NO DELAY TO THE SURGERY. THERE WAS REPORT OF NO INJURY TO THE PATIENT, NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED AND NO EXTENDED HOSPITALIZATION FOR THE PATIENT WAS REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14394710 ↗