NA 698343250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034498171), received between Nov 15, 2023 and Nov 28, 2023 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 28, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENT WAS BROKEN IN HALF DURING SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT INVOLVES ONE MODIFIED INSTRUMENT OSTEOTOME. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18217352 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT OCTOBER 20, 2023, THE SURGEON WAS USING OSTEOTOME FOR FACETECTOMIES AND WHILE MALLETING THE HANDLE BROKE. FRAGMENT WAS RETRIEVED. A NEW OSTEOTOME WAS USED FOR THE REMAINDER OF THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) MOD OSTEOTOME. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18139865 ↗