NA 92-08630Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327174113), received between Jun 13, 2019 and Jul 16, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2019Break

  IT WAS REPORTED THAT A PAIR OF BONE REDUCTION FORCEPS BROKE DURING A CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8795088 ↗
• MalfunctionJun 13, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A SURGICAL PROCEDURE THE BONE FORCEPS BROKE OFF INTO A PATIENT¿S MANDIBLE. 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 8697883 ↗