N/A 5820110050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327294804), received between Feb 24, 2020 and Feb 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BUR BROKE AND IS STUCK INSIDE THE ATTACHMENT, NO PARTS FELL INTO THE PATIENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS 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 9745551 ↗