OsteoMed 338-3532Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694043618), received between Jan 6, 2026 and Jan 6, 2026 — classified as 1 injury.

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.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "EIGHT YEARS PRIOR TO HIS SURGERY, THE PATIENT REPORTED A TRAUMATIC EVENT DUE TO A FALL FROM A FORMWORK ROOF, LANDING ON THE TIP AND IN ABDUCTION OF THE MIDFOOT, SUBSEQUENTLY PRESENTING OVER THE FOLLOWING YEARS WITH SIGNIFICANT ABDUCTION DEVIATION OF THE LEFT FOOT AT THE EXPENSE OF THE TALONAVICULAR JOINT. THEREFORE, AN ARTHRODESIS OF THE MEDIAL COLUMN OF THE LEFT FOOT WAS PERFORMED WITH A SPECIAL TITANIUM PLATE. THE PATIENT EVOLVED POORLY, WITH PAIN SINCE THE INITIATION OF WEIGHT-BEARING AT 12 WEEKS. AT 11 MONTHS, A REVISION SURGERY WAS PERFORMED, FINDING A TALONAVICULAR PSEUDARTHROSIS AND SEVERE METALLOSIS."

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23982171 ↗