NA 5120066012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540078612), received between Oct 24, 2018 and May 23, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2023Fracture; Overheating of Device; Fracture; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE REQUIRING METAL FRAGMENTS TO BE LOCATED. IT WAS ALSO REPORTED THAT THE EVENT CONTRIBUTED TO A 120 MINUTE DELAY. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A A BURN TO THE PATIENTS LIP AND A DEEP ABRASION OF THE LOWER LIP WHICH REQUIRED SUTURING. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT ADDRESSES ONE OF THE BUR BREAKS WHICH WAS REPORTED IN THIS EVENT.

  Patient problems: Burn(s); Laceration(s); Unspecified Tissue Injury

  MAUDE report 16983012 ↗
• InjuryMay 23, 2023Fracture; Overheating of Device; Fracture; Overheating of Device

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, TWO BURS BROKE REQUIRING METAL FRAGMENTS TO BE LOCATED. IT WAS ALSO REPORTED THAT THE EVENT CONTRIBUTED TO A 120 MINUTE DELAY. IT WAS FURTHER REPORTED THAT THE EVENT CAUSED A BURN TO THE PATIENTS LIP AND A DEEP ABRASION OF THE LOWER LIP WHICH REQUIRED SUTURING. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT ADDRESSES ONE OF THE BUR BREAKS WHICH WAS REPORTED IN THIS EVENT.

  Patient problems: Burn(s); Laceration(s); Unspecified Tissue Injury

  MAUDE report 16983011 ↗
• MalfunctionOct 24, 2018Break; Break

  IT WAS REPORTED DURING A MAXILLO FACIAL SURGERY OF DENTAL EXTRACTION WITH SUPERNUMERARY MANDIBULAR TOOTH THAT THE BUR BROKE DURING A SURGICAL PROCEDURE. IT WAS ALSO REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. IT WAS FURTHER REPORTED THAT A SECOND BUR WAS OPENED AND USED TO COMPLETE THE CASE, THERE WAS A MINOR DELAY TO RETRIEVE THE FRAGMENT. IT WAS ALSO REPORTED THAT THE BUR WHICH BROKE WAS REPROCESSED/REUSED. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001594 ↗