BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4913341 · Received July 14, 2015

    Report

    Report Number
    1030489-2015-01464
    Event Type
    Injury
    Date Received
    July 14, 2015
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERGOING TREATMENT WITH EPIDURAL INJECTIONS FOR PAIN MANAGEMENT TO TREAT CONTINUOUS BACK PAIN. ON (B)(6) 2010, PATIENT UNDERWENT SPINAL FUSION USING RHBMP-2/ ACS FROM L5-S1. PATIENT RECEIVED POST-OP TREATMENT IN THE FORM OF PHYSICAL THERAPY AFTER THE SURGERY. PATIENT WAS ABLE TO RETURN TO WORK IN (B)(6) 2010. HOWEVER, BY (B)(6) 2010, ELEVATED PAIN RETURNED. PATIENT RETURNED IN SEVERE PAIN. HE CONTINUED TO SUFFER FROM CONTINUOUS AND EXCRUCIATING PAIN IN THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455041 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 Other