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OsteoMed 214-0102Recalls & reported problems

Osteomed LLC · Short Left Reconstruction Plate w/Angle · Class 2 · Implant

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 00845694003742), received between Feb 14, 2020 and Feb 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Failure of Implant1

Recent adverse event reports

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

  • MalfunctionFeb 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    ON (B)(6) 2020 OSTEOMED WAS NOTIFIED OF A PATIENT DIAGNOSED ODONTOGENIC KERATOCYTES ANGULUS MANDIBULA SINISTRA, OPERATED WITH SEGMENTAL RESECTION AND USED OSTEOMED PLATE AND 7 PCS OF OTHER BRAND SCREW (OSTEONIC - MADE IN (B)(6). TWO (2) MONTH AFTER SURGERY (B)(6) 2019), OSTEOMED PLATE WAS FOUND TO BE BROKEN.

    Patient problems: Failure of Implant

    MAUDE report 9711550 ↗

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.