BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDII THREADED DOWEL 18X23

    MDR report key: 1603716 · Received February 17, 2010

    Report

    Report Number
    MW5014688
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    October 8, 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 SPINAL FUSION L4-L5, L5-S1, THE BONE DOWEL FRACTURED. A SECOND BONE DOWEL WAS PLACED THAT ALSO FRACTURED IN HALF, LEAVING THE DEEP HALF FIRMLY IMBEDDED. BOTH DOWELS WERE FIRMLY FIXED AND SOLID. THE PT DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MDII THREADED DOWEL 18X23 BONE DOWEL MQY SPINAL GRAFT TECHNOLOGIES, LLC 5142153 101063713
    2 MDII THREADED DOWEL 18X23 BONE DOWEL MQY SPINAL GRAFT TECHNOLOGIES, LLC 5137977 101064033

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other SOFAMOR DANEK INFUSE BONE GRAFT LARGE II KIT