BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFTCAGE

    MDR report key: 688941 · Received March 13, 2006

    Report

    Report Number
    2246640-2006-00001
    Event Type
    Malfunction
    Date Received
    March 13, 2006
    Date of Event
    February 8, 2006
    Report Date
    February 16, 2006
    Manufacturer
    OSTEOTECH, INC.
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS ATTEMPTING TO INSERT THE DEVICE INTO A TIGHT SPACE. HE INITIALLY INSERTED THE DEVICE OBLIQUELY, THEN USED SEVERAL DIFFERENT TAMPS IN VARIOUS WAYS IN AN EFFORT TO MAKE THE DEVICE FIT TRANSVERSELY. AS THE SURGEON WAS PERFORMING THIS, A PORTION OF THE DEVICE BROKE OFF FROM THE REST OF THE DEVICE. THE SURGEON REMOVED THE BROKEN PIECE, LEAVING THE REST OF THE DEVICE IN PLACE AND PROCEEDED TO COMPLETE THE SURGERY BY PLACING GRAFTING MATERIAL AROUND THE DEVICE. THE SURGERY WAS PROLONGED LESS THAN 5 MINUTES AS A RESULT OF THE INCIDENT. THE SURGEON IS REPORTEDLY NOT PLANNING ON ANY REVISION OR ADDITIONAL SURGERY AT THIS TIME, AND IS CONTENT TO LEAVE EVERYTHING AS IS AND WAIT TO SEE HOW THE FUSION AT THE SURGICAL SITE PROGRESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAFTCAGE VERTEBRAL BODY REPLACEMENT DEVICE MQP OSTEOTECH, INC. TLX AN52840-001

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR