BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTCAGE

    MDR report key: 698692 · Received April 7, 2006

    Report

    Report Number
    2246640-2006-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2006
    Date of Event
    March 7, 2006
    Report Date
    March 16, 2006
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AS SURGEON WAS ATTEMPTING TO IMPLANT THE DEVICE BY IMPACTING THE INSERTER TO WHICH THE DEVICE WAS ATTACHED, THE DEVICE CRACKED. THE SURGEON PERFORMED ADDITIONAL WORK ON THE IMPLANT SITE TO ACCOMMODATE THE DEVICE, THEN IMPLANTED ANOTHER DEVICE OF THE SAME KIND WITHOUT ANY DIFFICULTY. THE INCIDENT REPORTEDLY EXTENDED THE SURGERY ONLY ABOUT TWO MINUTES. THE PT WAS REPORTEDLY DOING FINE FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTCAGE VERTEBRAL BODY REPLACEMENT DEVICE MQP OSTEOTECH, INC. TLX AN53011-025

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR