NA 5400703000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540604125), received between Nov 24, 2020 and Nov 24, 2020 — 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.

• MalfunctionNov 24, 2020Flaked; Flaked

  THE USER FACILITY REPORTED THAT THEY FOUND THREE PLASTIC FRAGMENTS ALONG WITH THE BONE CHIPS FROM THE PATIENT'S BODY DURING A PROCEDURE. THE THREE PLASTICS PIECES WERE RETRIEVE FROM THE PATIENT'S BODY. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896754 ↗