BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XL FIXATION CAGE

    MDR report key: 2100933 · Received May 19, 2011

    Report

    Report Number
    MW5020672
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 13, 2011
    Manufacturer
    NUVASIVE SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SCREW IMPLANT LOCKING MECHANISM IS UNCONVENTIONAL AND UNRELIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XL FIXATION CAGE INTERBODY CAGE + PLATE KWQ NUVASIVE SPINE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other