BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3161718 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02145
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    December 5, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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 SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, THE PATIENT UNDERWENT A L4-S1 INTERBODY FUSION WITH PEEK CAGE FILLED WITH RHBMP -2/ACS AND MORSELLIZED AUTOGRAFT AND THE BILATERAL LATERAL ALLOGRAFT FUSION USING INFUSE RHBMP -2/ACS. ON (B)(6), 2010, THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE: THE THORACIC LAMINOTOMY AND PLACEMENT OF DORSAL COLUM STIMULATOR EPIDURAL ELECTRODES AND THE PROGRAMMING OF DORSAL COLUMN STIMULATOR DEVICE. THE PATIENT'S PAIN REPORTEDLY DID NOT SUBSIDE AND NOW SUFFERS FROM SEVERE INJURIES AND DAMAGES, INCLUDING CHRONIC PAIN SYNDROME, LEG PAIN, BACK PAIN, UNWANTED BONE GROWTH, OBESITY, CYST FORMATION, BULGING DISCS, AND NARCOTIC DEPENDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263288 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