BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTI CUSTOM PRO SPORT LEFT

    MDR report key: 1873043 · Received October 14, 2010

    Report

    Report Number
    3026585-2010-00004
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 13, 2010
    Manufacturer
    OSSUR
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PLAYING IN A FOOTBALL GAME AND USING A CTI PRO SPORT BRACE WHEN HE RE-TORE HIS ANTERIOR CRUCIATE LIGAMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CTI CUSTOM PRO SPORT LEFT ORTHOSIS, LIMB BRACE IQI OSSUR B-117600010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention