CONMED 00509122600Recalls & reported problems
Conmed Corporation · ROUND BUR, MEDIUM, CARBIDE 3 MM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854007358), received between Mar 24, 2021 and Mar 24, 2021 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2021Material Fragmentation; Material Fragmentation
ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE CONMED 3MM ROUND BUR MEDIUM, CARBIDE, ITEM # 00509122600 (5091-226) LOT 1123936 THAT (B)(6) RECENTLY EXPERIENCED. IT WAS REPORTED THAT DURING A PROCEDURE ON OR ABOUT (B)(6) 2021, THE BUR BROKE DURING USE. IT IS INDICATED THE TIP OF THE BUR COULD NOT BE RETRIEVED AND IT WAS LEFT IN THE PATIENT, HOWEVER IT IS ALSO NOTED THERE WAS NO PATIENT IMPACT OR INJURY. TO DATE, ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, NO INFORMATION HAS BEEN MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY SINCE THE FRAGMENT IS NOTED TO HAVE BEEN LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11562760 ↗
Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices
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- NA 310.21Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY29 reports
- NA 351.27Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Arthrex® AR-8500OBEArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY27 reports
- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
- Arthrex® AR-8150PX-45Arthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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