OsteoMed 336-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694049689), received between May 28, 2019 and May 28, 2019 — 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.

• MalfunctionMay 28, 2019Break; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD SURGERY PREVIOUSLY FOR AN ANKLE FRACTURE THAT IS COMMONLY CORRECTED BY THE USE OF THE 1/3 TUBULAR PLATE AND SCREWS. IMPLANTS AND SURGERY WENT WELL. THE PATIENT REVISITED WITH THE PHYSICIAN AND FOUND THAT THE PLATE WAS BROKEN POST-OP. ON (B)(6) 2019, THE PHYSICIAN PERFORMED A HARDWARE REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8646368 ↗