BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTI CUSTOM STANDARD RIGHT

    MDR report key: 3170440 · Received June 10, 2013

    Report

    Report Number
    3026585-2013-00003
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 11, 2013
    Report Date
    June 10, 2013
    Manufacturer
    OSSUR
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A PREVIOUS INJURY BUT WAS CLEARED TO PLAY SOCCER BY HIS DOCTOR. HE WAS PLAYING GOALIE WHILE WEARING THE CTI BRACE. HE STEPPED AND TWISTED AND RE-TORE HIS ACL AND MCL. THE PATIENT WILL REQUIRE AN ADD'L SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261593 CTI CUSTOM STANDARD RIGHT ORTHOSIS, LIMB BRACE IQI OSSUR B-116500010 8/2012

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| R