OsteoMed 209-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694001052), received between May 8, 2024 and May 8, 2024 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 8, 2024Break; Break

  IT WAS REPORTED THE PART NUMBER 209-2011-SP-01 SCREW BROKE DURING INSERTION IN THE PATIENT'S MANDIBLE DURING SURGERY. THE SURGEON WAS ABLE TO EXTRACT AND RECOVER THE BROKEN PORTION OF THE SCREW FROM THE PATIENT. THIS ISSUE PROLONGED THE SURGERY BY 30 MINUTES. NO OTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19268345 ↗