NA 0277010210Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540050489), received between Aug 9, 2022 and Jan 23, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 2 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163723 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. ONE EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398293 ↗
• MalfunctionApr 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THREE BURS BROKE WHILE CUTTING, A PIECE OF THE BROKEN BURR HAD TO BE RECOVERED FROM THE PATIENT'S GUM, RESULTING IN A THIRTY MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE THIRD BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682530 ↗
• MalfunctionApr 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THREE BURS BROKE WHILE CUTTING, A PIECE OF THE BROKEN BURR HAD TO BE RECOVERED FROM THE PATIENT'S GUM, RESULTING IN A THIRTY MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE FIRST BUR THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681813 ↗
• MalfunctionApr 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THREE BURS BROKE WHILE CUTTING, A PIECE OF THE BROKEN BURR HAD TO BE RECOVERED FROM THE PATIENT'S GUM, RESULTING IN A THIRTY MINUTE DELAY. 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 16681809 ↗
• MalfunctionNov 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT UPON DISPENSING ON THE STERILE FIELD, THAT THE TIP OF THE BUR IS MISSING. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821456 ↗
• MalfunctionAug 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BUR WAS FOUND BROKEN IN THE PACKAGING. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15196049 ↗