NA 50-23501Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540579867), received between Jun 15, 2018 and Jun 15, 2018 — classified as 1 malfunction.

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

• MalfunctionJun 15, 2018Break

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A MANDIBLE FRACTURE PROCEDURE THE SCREW HEAD BROKE OFF FROM THE THREAD PART OF THE SCREW. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605089 ↗