NA 5820012040Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540346520), received between Dec 20, 2022 and Dec 20, 2022 — classified as 1 malfunction.

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

• MalfunctionDec 20, 2022Flaked; Fracture; Flaked; Fracture

  IT WAS REPORTED THAT DURING A LUMBER SURGICAL PROCEDURE, THE BUR BROKE, 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 16018636 ↗