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OsteoMed 210-0320Recalls & reported problems

Osteomed LLC · 5mm Zygomatic Plate · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845694001960), received between Dec 27, 2022 and Dec 27, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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

  • Patient Device Interaction Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryDec 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THE PATIENT MIGHT BE DIAGNOSED WITH METALLOSIS (CLINICAL HYPOTHESIS), AND IT COULD BE RELATED TO THE IMPLANTED PLATES AND SCREWS. NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORT 40 OF 40 FOR THIS EVENT.

    Patient problems: Insufficient Information

    MAUDE report 16049411 ↗

Other SCREW, FIXATION, INTRAOSSEOUS devices

All SCREW, FIXATION, INTRAOSSEOUS devices →

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