NA 5120067021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540078643), received between Dec 13, 2021 and Dec 13, 2021 — 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 18, 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.

• MalfunctionDec 13, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE BUR BROKE OFF IN THE ATTACHMENT. IT WAS ALSO REPORTED THAT AN X-RAY WAS TAKEN TO ENSURE THAT NO BROKEN PIECES WERE NOT LEFT BEHIND IN THE PATIENT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12986875 ↗