BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2863092 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02700
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN L4-S1 SURGERY TO REMOVE HARDWARE AND PERFORM AN ANTERIOR FUSION WITH ALLOGRAFT (NOT A CAGE) AND RHBMP-2ACS FOLLOWED BY POSTERIOR FIXATION. THE SURGEON CONTINUED TO FOLLOW THE PATIENT WHO COMPLAINED OF LEG PAIN. ON FOLLOW-UP, THE ANTERIOR INTERBODY FUSION WAS SUCCESSFUL, BUT NOT THE POSTERIOR FUSION. AT 292 DAYS POST-OP, THE SURGEON PERFORMED A REVISION SURGERY DUE TO S1 DISTRIBUTION LEG PAIN. THE RIGHT S1 SCREW WAS REMOVED, A DECOMPRESSION PERFORMED, AND CRM, RHBMP-2/ACS, AND POSTERIOR INSTRUMENTATION WERE IMPLANTED AT L4-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention