N/A 1882569HS (UDI 20721902978009)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20721902978009), received between Mar 31, 2017 and Feb 21, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2020Material Separation; Material Separation

  A HEALTHCARE PROVIDER REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BUR HEAD BROKE OFF INSIDE THE PATIENT. THE HCP USED A DCR BUR AT 30,000 RPM INSTEAD OF THE INDICATED 12,000 RPM. THE BUR HEAD WAS REMOVED, AN X-RAY WAS PERFORMED TO CHECK THAT NO METAL REMAINED IN THE PATIENT. THE PROCEDURE WAS DELAYED FOR 60 MINUTES. THE BUR WAS STUCK INSIDE THE HANDPIECE. A DIFFERENT HANDPIECE WAS USED TO FINISH THE PROCEDURE. THE PATIENT WAS NOT INJURED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9738993 ↗
• MalfunctionAug 15, 2018Break; Break

  THE BUR BROKE AFTER 20 MINUTES OF USING. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784038 ↗
• MalfunctionJul 11, 2018Overheating of Device; Use of Device Problem; Unintended Movement; Use of Device Problem

  DURING USE, THE BUR OVER-HEATED AND THE SHAFT WOBBLED. THIS IS A BRAND NEW BUR. THERE WAS NO PATIENT IMPACT OR INJURY. THE PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678912 ↗
• MalfunctionJul 11, 2018Overheating of Device; Use of Device Problem; Use of Device Problem

  DURING USE, THE BUR OVER-HEATED AND THE SHAFT WOBBLED. THIS IA A BRAND NEW BUR. THERE WAS NO PATIENT IMPACT OR INJURY. THE PROCEDURE WAS COMPLETED WITH BACK-UP PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7678876 ↗
• MalfunctionMar 31, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A HIGH SPEED BUR BROKE OFF 2CM FROM THE TIP AND INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED WITHOUT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6450382 ↗