BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4940299 · Received July 24, 2015

    Report

    Report Number
    1030489-2015-01667
    Event Type
    Injury
    Date Received
    July 24, 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)(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 IN 2008, THE PATIENT PRESENTED WITH MID-BACK AND NECK PAIN, AND THE SURGEON INFORMED HER THAT SHE HAD A DISC BULGING INTO HER SPINAL CORD. LATER IN 2008 THE SURGEON PERFORMED A NECK SURGERY. IMMEDIATELY FOLLOWING THE SURGERY, PATIENT'S PAIN INCREASED AND THORACIC SURGERY WAS RECOMMENDED. IN (B)(6) 2009, THE SURGEON PERFORMED A SPINAL C5-6 SURGERY. AFTER THE SECOND SURGERY, THE PATIENT BEGAN HAVING INTENSE AND EXTREME PAIN. AGAIN IN THE EARLY 2010, THE SURGEON PERFORMED SURGERY ON THE T2-T4 AREA OF THE PATIENT'S SPINE. FOLLOWING THIS SURGERY, PAIN INCREASED AND BECAME UNBEARABLE. ALLEGEDLY, THE SURGEON INFORMED THE PATIENT THAT THE HARDWARE HAD COME AWAY FROM THE BONE AT THE NECK AREA. IN TOTAL, THE PATIENT UNDERWENT SEVEN SURGERIES IN FOUR YEARS TO IMPLANT AND THEN REPLACE HARDWARE. THE PATIENT STILL HAS EXCRUCIATING PAIN, LOSS OF FEELING IN HER NECK,MID-BACK AND SOMETIMES LOWER BACK. THE PATIENT LAST WENT FOR THE DOCTOR'S VISIT IN (B)(6) OF 2013. RHBMP-2/ACS WAS USED IN THE PATIENT'S SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481961 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