EXPEDIUM 279755300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034473154), received between Apr 12, 2023 and Sep 6, 2024 — 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.

• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024 THE INSTRUMENTS BROKE INTRAOPERATIVELY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) V OSTEOTOME. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163091 ↗
• MalfunctionApr 12, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS CHIPPED DURING USE AND WAS DISCARDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FRAGMENTS WERE GENERATED, AND THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE EXPEDIUM OSTEOTOMY SET V OSTEOTOME. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726023 ↗