OsteoMed 202-2014Recalls & reported problems
Osteomed LLC · 2.0mm x 14mm Screw · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845694000376), received between Dec 27, 2022 and Dec 27, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Patient Device Interaction Problem3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 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 36 OF 40 FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 16049343 ↗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 34 OF 40 FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 16049335 ↗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 35 OF 40 FOR THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 16049332 ↗
Other SCREW, FIXATION, INTRAOSSEOUS devices
- MatrixMIDFACE 04.503.226.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 400.736ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- OsteoMed 204-1206Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS14 reports
- NA 201.928Synthes GmbH · 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
- MatrixMIDFACE 04.503.204.01Synthes 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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