BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTCAGE

    MDR report key: 704840 · Received April 21, 2006

    Report

    Report Number
    2246640-2006-00004
    Event Type
    Malfunction
    Date Received
    April 21, 2006
    Date of Event
    March 20, 2006
    Report Date
    March 22, 2006
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE BROKE AS THE SURGEON WAS ATTEMPTING TO IMPLANT THE DEVICE BY USING A MALLET TO IMPACT THE INSERTER TO WHICH THE DEVICE WAS ATTACHED. SURGEON REMOVED THE BROKEN DEVICE AND THEN IMPLANTED A SMALLER SIZE OF THE DEVICE WITHOUT ANY PROBLEM. THE SURGERY WAS PROLONGED APPROX 5 MINUTES BY THE INCIDENT. THE PT WAS REPORTED TO BE IN FINE CONDITION FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTCAGE VERTEBRAL BODY REPLACEMENT DEVICE MQP OSTEOTECH, INC. TLX AN53011-21

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR