BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDII THREADED DOWEL 16X20

    MDR report key: 1603713 · Received February 17, 2010

    Report

    Report Number
    MW5014687
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    December 4, 2009
    Report Date
    January 29, 2010
    Manufacturer
    SPINAL GRAFT TECHNOLOGIES, LLC
    Product Code
    MQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ANTERIOR/POSTERIOR L3-L4, L4-L5, L5-S1 FUSION UPON SEEDING A SECOND BONE DOWEL, THE DOWEL CRACKED IN HALF. BONE MORPHOGENIC PROTEIN AND THE ANTERIOR PART OF THE BONE DOWEL REMAINED IN PLACE. THE SPINE WAS VERY STABLE AT THIS POINT AND NO BODY FRAGMENTS COULD BE REMOVED. THE PT DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MDII THREADED DOWEL 16X20 BONE DOWEL MQY SPINAL GRAFT TECHNOLOGIES, LLC 5380605 101064443

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other SOFAMOR DANEK INFUSE BONE GRAFT LARGE KIT