N/A 31315066URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20885074524805), received between Nov 5, 2018 and Dec 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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

Recent adverse event reports

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

• MalfunctionDec 26, 2018Material Separation; Material Separation

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT A SMALL FRAGMENT OF THE BUR WAS CHIPPED WHILE IN USE BY THE SURGEON DURING A MASTOIDECTOMY PROCEDURE. THE SURGEON WAS ABLE TO LOCATE AND REMOVE THE FRAGMENT WHICH WAS EASILY FOUND FROM THE SURGICAL SITE. THERE WAS ONLY A MINIMAL DELAY IN THE PROCEDURE DUE TO CHANGING OF BUR AND REMOVING THE FRAGMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196028 ↗
• MalfunctionNov 5, 2018Vibration; Vibration

  A HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REPORTED THAT A BUR WAS VIBRATING DURING THE PROCEDURE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037213 ↗