N/A 31130571Recalls & reported problems
Medtronic Xomed, Inc. · BUR 31130571 0.5MM FINE DIAMOND LONG · 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 00885074496641), received between Aug 11, 2017 and Aug 11, 2017 — 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
- Nerve Damage1
- Vertigo1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2017Material Fragmentation; Material Fragmentation
PER SUS VOLUNTARY EVENT REPORT: MW5070751: "ROUGH FINE DIAMOND BUR 0.5 MM USED TO DRILL COCHLEOSTOMY. PT HAD THICK BONE AND NEEDED INCREASED DRILLING, AT THE END OF THE DRILLING THE DRILL TIP BROKE OFF. THE SURGEON HAD DIFFICULTY REMOVING THE BROKEN TIP BECAUSE IT HAD LODGED INTO THE BONE SO HE ENDED UP MAKING THE COCHLEOSTOMY WIDER WHICH MAY HAVE CAUSED INJURY TO THE FACIAL NERVE. POST OP VERTIGO."
Patient problems: Nerve Damage; Vertigo
MAUDE report 6788984 ↗
Other BUR, EAR, NOSE AND THROAT devices
- Quadcut® 1884380HRMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall7 reports
- Silver Bullet® 1882905HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall3 reports
- Diego Elite MBUR6060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall2 reports
- Quadcut® 1884380HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- RAD® 1882916Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall1 report
- N/A 1884032Medtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 reports
- DIEGO ELITE MBUR5060FRCVGyrus ACMI, LLC · BUR, EAR, NOSE AND THROAT1 recall0 reports
- Tricut® 1884033HREMedtronic Xomed, Inc. · BUR, EAR, NOSE AND THROAT1 recall0 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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