BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 290318 · Received August 9, 2000

    Report

    Report Number
    2242816-2000-00025
    Event Type
    Malfunction
    Date Received
    August 9, 2000
    Report Date
    August 9, 2000
    Manufacturer
    EBI, L.P.
    Product Code
    HTY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS APPLIED TO TREAT A DISTAL RADIUS FRACTURE. AT THE SIX WEEK F/U VISIT, THE MD LOOSENED THE BALL JOINT TO MAKE SOME ADJUSTMENTS TO THE FRACTURE. WHEN HE ATTEMPTED TO RETIGHTEN THE BALL JOINT IT APPEARED TO "SPRING BACK" TO THE LOOSENED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX EXTERNAL FIXATION HTY EBI, L.P. 04003 213373

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other