BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTI CUSTOM STANDARD LEFT

    MDR report key: 2032296 · Received March 22, 2011

    Report

    Report Number
    3026585-2011-00002
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 15, 2011
    Report Date
    March 21, 2011
    Manufacturer
    OSSUR
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT LANDED A JUMP DURING MOTOCROSS EVENT WHILE WEARING A CTI CUSTOM KNEE BRACE AND FELT PAIN AFTER HE LANDED THE JUMP. PT SUFFERED A COMPLETE ACL TEAR, PARTIAL PCL TEAR, LATERAL BUCKET HANDLE TEAR OF THE MENISCUS AND OTHER INTERNAL DERANGEMENT OF THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CTI CUSTOM STANDARD LEFT IQI OSSUR B-116600010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization