BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVOLVE RADIAL HEAD

    MDR report key: 1009727 · Received March 7, 2008

    Report

    Report Number
    1043534-2008-00034
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    November 26, 2007
    Report Date
    February 26, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWI
    PMA / PMN Number
    K991915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    ORIG SURG 2007. ALLEGEDLY PRODUCT WAS TOO SHORT AFTER SURGEON COMPLETED CUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLVE RADIAL HEAD KWI WRIGHT MEDICAL TECHNOLOGY, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization