NA 5820013140Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540374295), received between Jul 24, 2018 and Dec 16, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionDec 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE DURING A SPINAL DECOMPRESSION SURGICAL PROCEDURE, A BUR BROKE AT THE CUTTING END. IT WAS FURTHER REPORTED A SPARE WAS USED. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475338 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE AT THE CUTTING END. 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 SPARE BUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811408 ↗
• MalfunctionJul 24, 2018Break; Break

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE BROKE DURING A SPINAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714617 ↗