N/A 5820110020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327294699), received between May 22, 2019 and Nov 30, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE. THE SURGEON WAS UNABLE TO BE RETRIEVE THE BROKEN FRAGMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 18236284 ↗
• MalfunctionAug 21, 2019Break; Break

  IT WAS REPORTED THAT THE BUR BROKE AT THE SHAFT DURING A LUMBAR FUSION. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW BUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915453 ↗
• InjuryJul 10, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE BUR BROKE AT THE NECK DURING A LUMBAR FUSION. IT WAS FURTHER REPORTED THAT THE A PIECE OF THE BUR HAD TO BE REMOVED FROM THE PATIENT'S BONE. IT WAS ALSO REPORTED THAT THERE WAS A 10 TO 20 MINUTE DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775389 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE BUR BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8687204 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE BUR BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8687202 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE BUR BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8687198 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE BUR BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8687197 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE BUR BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8687095 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE BUR BROKE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8687094 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED THAT THE SHAFT OF THE BUR BROKE DURING A SPINAL PROCEDURE. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY TO GET A NEW BUR AND DRILL TO REMOVE TIP. IT WAS FURTHER REPORTED THAT A X-RAY WAS PERFORMED TO CONFIRM REMOVAL. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8632289 ↗