BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 179236 · Received July 27, 1998

    Report

    Report Number
    2242816-1998-00037
    Event Type
    Injury
    Date Received
    July 27, 1998
    Date of Event
    May 1, 1998
    Report Date
    July 20, 1998
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS APPLIED TO THE PT'S PHALANX. SEVERAL DAYS AFTER APPLICATION, THE BONE PIN BROKE OFF. THE FIXATOR WAS REMOVED AND THE PT PLACED IN A BRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX EXTERNAL FIXATOR HTX EBI MEDICAL SYSTEMS, INC. 07000 029297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention