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NA 1608002035Recalls & reported problems

Stryker Corporation · 4.0mm Egg Bur · Class 1

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 04546540030580), received between Feb 7, 2019 and Feb 7, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break2

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 7, 2019Break; Break

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE IN THE ATTACHMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8314936 ↗
  • MalfunctionFeb 7, 2019Break; Break

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE IN THE ATTACHMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8314890 ↗

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.