NA 5820010120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540346353), received between Mar 23, 2022 and Nov 23, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE THE BUR BROKE ALONG THE SHAFT OF THE BUR. IT WAS ALSO REPORTED THERE WERE NO DELAYS, ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION 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 15854867 ↗
• MalfunctionNov 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TLIF PROCEDURE, THE BUR BROKE WHILE DRILLING FOR PEDICLE SCREW PILOT HOLES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15842692 ↗
• InjuryMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHILE DRILLING PILOT HOLES IN A POSTERIOR SPINAL FUSION, THE BUR BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECES HAD TO BE DRILLED OUT OF THE PEDICLE HOLE. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF LESS THAN FIFTEEN MINUTES AS A RESULT OF THIS EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863084 ↗
• InjuryMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT WHILE DRILLING PILOT HOLES IN A POSTERIOR SPINAL FUSION, THE BUR BROKE. IT WAS ALSO REPORTED THAT THE BROKEN PIECES HAD TO BE DRILLED OUT OF THE PEDICLE HOLE. IT WAS FURTHER REPORTED THAT THERE WAS A DELAY OF LESS THAN FIFTEEN MINUTES AS A RESULT OF THIS EVENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862788 ↗