BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EBI XFIX DYNAFIX

    MDR report key: 494358 · Received November 6, 2003

    Report

    Report Number
    2242816-2003-00016
    Event Type
    Injury
    Date Received
    November 6, 2003
    Report Date
    November 3, 2003
    Manufacturer
    EBI, L.P.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE BONE SCREW CLAMPS LOOSENED. ALLOWING THE ROD TO MOVE. A SECOND SURGERY WAS PERFORMED TO REPLACE THE FIXATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI XFIX DYNAFIX EXTERNAL FIXATION HTY EBI, L.P. 04350 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other