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CONMED 00509123600Recalls & reported problems

Conmed Corporation · OVAL BUR, MEDIUM, 4 X 8 MM · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854007488), received between Jan 19, 2018 and Jan 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Device problems

  • Break1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJan 19, 2018Break; Break

    A CUSTOMER REPORTED DURING A SHOULDER SURGERY, THE HEAD OF A 00509123600 OVAL BUR BROKE. FOLLOW-UP CONFIRMED THE BREAKAGE OCCURRED WHILE THE BUR WAS TESTED BY THE NURSE BEFORE START OF SURGERY. THE BUR DID NOT BREAK IN THE PATIENT AND ALL BROKEN PIECES WERE ACCOUNTED FOR. AN ALTERNATIVE BUR WAS USED IN A MICROPOWER PLUS DRILL ON THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A TEN MINUTE SURGICAL DELAY. NO PATIENT INJURY WAS REPORTED. THIS REPORTED IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

    Patient problems: No Patient Involvement

    MAUDE report 7207353 ↗

Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices

All BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices →

Sources and updates

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