BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 173247 · Received June 19, 1998

    Report

    Report Number
    2242816-1998-00032
    Event Type
    Injury
    Date Received
    June 19, 1998
    Report Date
    June 19, 1998
    Manufacturer
    EBI MEDICAL SYSTEMS, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A FIXATOR WAS BEING APPLIED TO TREAT A DISTAL RADIUS FRACTURE. WHILE INSERTING A BONE SCREW INTO THE PT'S RADIUS THE SCREW BROKE. MD COMPLETED THE PROCEDURE USING ANOTHER SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX Implant EXTERNAL FIXATION HTY EBI MEDICAL SYSTEMS, INC. A30-07020 025063

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention