BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI STABLE AF

    MDR report key: 23658870 · Received November 26, 2025

    Report

    Report Number
    3007289093-2025-00015
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 26, 2025
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HRS
    PMA / PMN Number
    K212297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ANTERIOR TIBIA PLATE FRACTURED IN TWO SITES POST-OPERATIVELY. SURGEON SUSPECTS THE FRACTURE OCCURRED SHORTLY AFTER SURGERY AS THE PATIENT REPORTED A MINOR "FUMBLE", ALTHOUGH NO X-RAYS WERE TAKEN AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2672162 OMNI STABLE AF BONE PLATE HRS EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown