OsteoMed 210-0300Recalls & reported problems
Osteomed LLC · 5mm Zygomatic Rigid Plate · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845694001878), received between Dec 27, 2022 and Dec 27, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).
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
Device problems
- Patient Device Interaction Problem2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 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 39 OF 40 FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 16049441 ↗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 16049337 ↗
Other SCREW, FIXATION, INTRAOSSEOUS devices
- MatrixMIDFACE 04.503.226.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 400.736ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 201.928Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS14 reports
- OsteoMed 204-1206Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS14 reports
- LEVEL ONE CMF 25-092-12-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS11 reports
- OsteoMed 202-2016Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS9 reports
- LEVEL ONE CMF 25-092-08-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS9 reports
- PlusDrive 401.062ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS8 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page