BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM OTS RIGHT MED

    MDR report key: 2624251 · Received February 24, 2010

    Report

    Report Number
    3026585-2010-00007
    Event Type
    Injury
    Date Received
    February 24, 2010
    Date of Event
    January 13, 2010
    Report Date
    February 16, 2010
    Manufacturer
    OSSUR AMERICAS
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO LIGAMENT BRACE IS PURPORTED TO PREVENT ACL INJURY. THE ML STABILITY OF THIS BRACE IS COMPROMISED SOMEWHAT FROM WEAR. THE DATE CODE ON THE HINGE APPEARS TO READ JANUARY 2006. THE WEAR OF THIS BRACE IS WITHIN EXPECTED AND ACCEPTABLE LIMITS AND WOULD IN NO WAY BE ATTRIBUTED TO ACL TEAR.

    Description of Event or Problem · 1

    PT RE-TORE ACL PLAYING FOOTBALL WHILE WEARING THE BRACE. PT AND MEDICAL PRACTITIONER ARE NOT CLAIMING THE BRACE FAILED OR CAUSED THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM OTS RIGHT MED IQI OSSUR AMERICAS B-210500003

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention