Skip to content

OsteoMed 336-2777Recalls & reported problems

Osteomed LLC · 2.7mm 1st Transfixation MTP Fusion Plate, Right 10/10 Degree · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694041850), received between Mar 6, 2019 and Mar 6, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 6, 2019Break

    ON (B)(6) 2019, OSTEOMED WAS NOTIFIED OF AN INCIDENT THAT OCCURRED WITH OUR 2.7MM - 1ST TRANSFIXATION MTP FUSION PLATE RIGHT - 10° (P/N 336-2777). PER THE DISTRIBUTOR, THE PLATE WAS IMPLANTED ON (B)(6) 2019, AND WAS A REVISION PROCEDURE AFTER A COMPETITOR PLATE (BELIEVED TO BE AN ANCHORAGE PLATE) BROKE. DURING THE PATIENT'S 6 WEEK UP CHECK, NOW APPEARS TO SHOW THE REVISION PLATE IS BROKEN.

    Patient problems: No Information

    MAUDE report 8396375 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.