Henry Schein 1022417Recalls & reported problems
Henry Schein, Inc. · Carbide Bur Surgical Bone · Class 1
Data updated Oct 13, 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 00304040071502), received between Mar 5, 2024 and Mar 5, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
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 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
WHILE A 35 YEAR OLD MALE PATIENT WAS HAVING A DENTAL SURGICAL EXTRACTION PROCEDURE THE PATIENT HEARD THE NOISE OF THE DRILL AND FELT THE VIBRATION AND CLAMPED DOWN ON THE HANDPIECE CLOSING HIS MOUTH. THIS MOTION DISLODGED THE BUR OUT OF THE HANDPIECE. THE PATIENT BEGAN TO COUGH MAKING IT DIFFICULT TO CAPTURE THE BUR WITH BOTH HIGH SPEED SUCTIONS IN THE MOUTH OF THE PATIENT. THE PATIENT WAS INSTRUCTED TO SIT UP AND COUGH HOWEVER THE BUR WAS NOT RECOVERED. THE PATIENT WAS IN GOOD CONDITION. THE PATIENT WAS GIVEN A REFERRAL FOR A CHEST RADIOGRAPH AND INSTRUCTED TO GO AS SOON AS POSSIBLE FOR LOCATING THE BUR. AS OF THE DATE OF THIS REPORT, THE REPORTER STATED THE PATIENT HAS NOT GONE TO GET AN X-RAY.
Patient problems: Foreign Body In Patient
MAUDE report 18839754 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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