NA 5820070011Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540362391), received between Jul 24, 2018 and Apr 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876060 ↗
• MalfunctionJul 24, 2024Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTED FOUND TO HAVE A TEAR, RIP, OR HOLE IN THE DEVICE PACKAGING. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818504 ↗
• MalfunctionNov 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE BUR BROKE AND A PIECE OF THE BUR WAS RETAINED IN THE SKULL DURING A CRANIOTOMY. 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 9318125 ↗
• MalfunctionOct 22, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE BUR BROKE DURING A CRANIOTOMY. IT WAS ALSO REPORTED THAT THE DOCTOR LEFT THE PIECE INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SPARE BUR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220803 ↗
• MalfunctionJul 24, 2018Break; Break

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

  Patient problems: No Patient Involvement

  MAUDE report 7714604 ↗