BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-WIRE 2X450MM

    MDR report key: 856290 · Received October 4, 2006

    Report

    Report Number
    2183449-2006-00013
    Event Type
    Malfunction
    Date Received
    October 4, 2006
    Report Date
    September 22, 2006
    Manufacturer
    ORTHOFIX SRL
    Product Code
    NDK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SHEFFIELD FRAME WAS APPLIED ON THE PT'S RIGHT FOOT FOR THE TREATMENT OF CHARCOT FOOT. DURING THE TREATMENT A WIRE BROKE BETWEEN THE 1ST METATARSAL AND FRAME. THE DR REMOVED THE WIRE AND REPLACED IT WITH A NEW ONE AND ANOTHER WIRE WAS INSERTED AS A SUPPORT. NO COMPRESSION WAS LOST AND THE PT CONTINUED TREATMENT WITH THE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-WIRE 2X450MM EXTERNAL FIXATION NDK ORTHOFIX SRL 80124 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR