BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREMER 3D CROWN

    MDR report key: 1935439 · Received November 10, 2010

    Report

    Report Number
    1526439-2010-00162
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    HBL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE. THE DEVICE REMAINS ON THE PT AND IS NOT AVAILABLE FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS UNK. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT TWO TO THREE DAYS AFTER INSTALLATION, THE 3D CROWN EXTERNAL BRACE HAD LOOSENED. AS PER PROCEDURE, THE DEVICE WAS RETIGHTENED. REPORTS THAT AFTER APPROX 2 WEEKS, THE DEVICE WAS STILL NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREMER 3D CROWN CERVICAL BRACE HBL DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK