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E9000 E8050LSORecalls & reported problems

Conmed Corporation · 5 X 30mm E9000 Fluted Low Speed Optimum Bur, Round, Carbide · 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 10845854011744), received between Jun 19, 2023 and Jun 19, 2023 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJun 19, 2023Material Fragmentation; Material Fragmentation

    THE CUSTOMER REPORTED THAT THE DEVICE, E8050LSO, 5 X 30MM E9000 FLUTED LOW SPEED OPTIMUM BUR, ROUND, WAS BEING USED DURING A COCHLEAR DEVICE IMPLANTATION LEFT EAR PROCEDURE ON (B)(6) 23 WHEN IT WAS REPORTED, ¿HEAD OF BUR "FELL OFF". THE FLUTED ROUND HEAD OF THE BUR BIT SHEARED OFF DURING USE. IT WAS RETRIEVED...¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17150816 ↗

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Sources and updates

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