BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA

    MDR report key: 1813302 · Received July 22, 2010

    Report

    Report Number
    1813302
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    July 6, 2010
    Manufacturer
    SYNTHES
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS NOT HAPPY WITH THE WAY 34MM SYNTHES PLATE WAS SITTING AFTER IMPLANTATION. PLATE WAS REMOVED AND SENT BACK TO COMPANY FOR EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI VECTRA CERVICAL PLATE KWQ SYNTHES * 3292062

    Patients

    Seq Age Sex Outcome Treatment
    1 *