BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTCAGE

    MDR report key: 794714 · Received December 5, 2006

    Report

    Report Number
    2246640-2006-00007
    Event Type
    Malfunction
    Date Received
    December 5, 2006
    Date of Event
    November 6, 2006
    Report Date
    November 7, 2006
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IMPLANT SPACE WAS PREPARED AND SIZED. SURGEON USED DISTRACTION AND INSERTED THE DEVICE. SURGEON THEN ATTEMPTED TO POSITION THE DEVICE WITH A TAMP AND THE DEVICE BROKE INTO SEVERAL PIECES. ALL PIECES WERE REMOVED FROM THE PATIENT AND A SMALLER (7MM) SIZE DEVICE WAS USED TO COMPLETE THE SURGERY. THE DELAY IN SURGERY WAS REPORTED TO BE APPROXIMATELY ONE HOUR. THERE WAS NO INJURY TO THE PATIENT REPORTED. AS OF TWENTY-THREE DAYS LATER THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTCAGE VERTEBRAL BODY REPLACEMENT DEVICE MQP OSTEOTECH, INC. TLX AN53015-030

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR