BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTI CUSTOM STANDARD LEFT

    MDR report key: 2384041 · Received December 15, 2011

    Report

    Report Number
    3026585-2011-00008
    Event Type
    Injury
    Date Received
    December 15, 2011
    Date of Event
    October 19, 2011
    Report Date
    December 13, 2011
    Manufacturer
    OSSUR
    Product Code
    IQI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LEFT BRACE: LOWER FRAME IS STARTING TO DELAMINATE FROM HINGE ARM ALTHOUGH THE COMPOSITE MATERIAL STILL FULLY ENCAPSULATES THE HINGE ARM. THERE IS NO FURTHER BRACE EXTENSION/FLEXION PAST THE NORMAL POINTS, HINGE MOTION TRACKS NORMALLY, AND THE BRACE IS STILL WEIGHT BEARING.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND STATED PT RE-INJURED (TORE ACL) HIS LEFT KNEE WHILE WEARING HIS CTI BRACE WHILE RIDING MOTOCROSS - CLAIMS FRAME FAILED AROUND THE HINGES. THE PT IS HAVING RECONSTRUCTIVE SURGERY ON (B)(6). HE WAS RIDING MOTOCROSS AND PUT FOOT OUT TO IMMOBILIZE HIMSELF WHILE TURNING. HIS FOOT SLIPPED, PUTTING EXTRA PRESSURE AT THE KNEE WHEN HIS ACL TORE.

    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 Hospitalization