BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 494988 · Received November 6, 2003

    Report

    Report Number
    2242816-2003-00017
    Event Type
    Malfunction
    Date Received
    November 6, 2003
    Date of Event
    October 15, 2003
    Report Date
    November 5, 2003
    Manufacturer
    EBI, L.P.
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE FIXATOR WAS ORIGINALLY APPLIED TO TREAT A DISTAL RADIUS FRACTURE. APPROXIMATELY ONE WEEK LATER, DURING A FOLLOW-UP VISIT, IT WAS NOTED THE FIXATOR WAS LOOSE. THE FIXATOR WAS TIGHTENED BUT SUBSEQUENTLY LOOSENED AGAIN. THE FIXATOR WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX ENTERNAL FIXATION KTT EBI, L.P. 04102 782800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other