BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILSON PLUS FRAME

    MDR report key: 1711475 · Received June 3, 2010

    Report

    Report Number
    MW5016156
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 21, 2010
    Manufacturer
    OSI - MIZUHO OSI
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POSITIONER BROKE WHILE USING THE CRANK. CRANKED X 3 AND HEARD CRACK, BACK OF WILSON FRAME BROKE. PT WAS SECURED AND SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON PLUS FRAME SPINE POSITIONER FWZ OSI - MIZUHO OSI 5321G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other