N/A 1883040BRCRecalls & reported problems
Medtronic Xomed, Inc. · BUR 1883040BRC RAD FRONTAL 40DEG 30K · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169434653), received between Sep 30, 2024 and Feb 10, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Vibration” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Vibration2
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2025Vibration; Mechanical Jam; Vibration; Mechanical Jam
IT WAS REPORTED THAT WHILE SETTING UP THE SHAVER, PLAY WAS IMMEDIATELY DETECTED AND IT DOES NOT MAKE ANY REVOLUTIONS. NO PROBLEM WHEN SETTING UP A NEW SHAVER AND IT WORKS IMMEDIATELY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21343173 ↗MalfunctionSep 30, 2024Vibration; Vibration
IT WAS REPORTED DURING INTRA-OP THAT THE DEVICE COULD NOT GET THE BUR TO STAY SEATED PROPERLY IN THE M5 HANDPIECE. IT WOULD ROTATE CORRECTLY INITIALLY (WHEN TESTING AS PART OF THE SETUP) BUT AS SOON AS THE BUR WAS BROUGHT INTO CONTACT WITH BONE IT WOULD SPIN OFF AND BECOME DISLODGED FROM THE HANDPIECE. THIS HAPPENED SEVERAL TIMES, ALMOST LIKE IT WOULD NOT SECURELY INSERT INTO THE HANDPIECE. THE ESTABLISHMENT ARE NOT ALLOWED TO KEEP CONTAMINATED ITEMS (SINCE THIS HAS ALREADY COME INTO CONTACT WITH THE PATIENT) SO THEY ARE UNABLE TO RETURN THE AFFECTED BUR FOR INVESTIGATION. THE SURGEON MENTIONED THIS HAS HAPPENED THE LAST 4 OR 5 TIMES HE HAS USED THIS BUR. PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCTS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20331739 ↗
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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