BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTCAGE

    MDR report key: 700913 · Received April 14, 2006

    Report

    Report Number
    2246640-2006-00003
    Event Type
    Malfunction
    Date Received
    April 14, 2006
    Date of Event
    March 16, 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

    SURGEON ATTEMPTE TO IMPLANT THE DEVICE IN A TIGHT SPACE BY USING A MALLET TO IMPACT THE INSERTER TO WHICH THE DEVICE WAS ATTACHED. THE DEVICE BROKE INTO TWO PIECES. THE PIECES WERE REMOVED AND THE SURGEON PERFORMED ADDITIONAL WORK ON THE IMPLANT SITE TO OPEN UP THE SPACE AND ACCOMMODATE THE DEVICE. HE THEN IMPLANTED ANOTHER DEVICE OF THE SAME KIND WITHOUT FURTHER INCIDENT. SURGERY WAS REPORTEDLY EXTENDED ONLY A COUPLE OF MINUTES BY THE INCIDENT. 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 AN53010-0XX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN