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NA 5300010903Recalls & reported problems

Stryker Corporation · 5.5mm Oval Solid Carbide Bur Medium · Class 1

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 07613153000624), received between Dec 12, 2022 and Dec 12, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

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.

  • MalfunctionDec 12, 2022Fracture; Fracture

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THAT TWO BURS BROKE RESULTING IN A DELAY OF FORTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE SECOND BUR THAT BROKE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15963791 ↗

Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices

All BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.