BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3923808 · Received July 9, 2014

    Report

    Report Number
    1030489-2014-03180
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    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 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 WAS EXPERIENCING SCIATIC NERVE PAIN IN HIS LEFT LEG, PAIN IN HIS MIDDLE AND LOWER BACK, AND NUMBNESS IN HIS LEFT ARM AND HAND AS THE RESULT OF SCOLIOSIS. ON (B)(6) 2010, PATIENT UNDERWENT A THORACIC AND LUMBAR FUSION PROCEDURE AT AN UNKNOWN LEVEL USING RHBMP-2/ACS WITH THE INSTALLATION OF HARDWARE INCLUDING RODS AND CAGES. IT WAS REPORTED THAT PATIENT WAS UNDER ANESTHESIA FOR MORE THAN TEN AND A HALF HOURS. PATIENT WAS TOLD THAT HE HAD CODED AND HAD TO BE REVIVED FOUR TIMES WHILE IN THE RECOVERY ROOM. FOLLOWING THE SURGERY, PATIENT BEGAN TO SUFFER FROM INTENSE PAIN IN HIS SIDE BELOW HIS RIGHT ARM. THIS PAIN WAS TREATED WITH MEDICATION IN THE HOSPITAL. ON (B)(6) 2010 PATIENT WAS SUFFERING FROM SO MUCH PAIN THAT IT INTERFERED WITH HIS ABILITY TO BREATHE. HE RETURNED TO ER FOR MORE MEDICATION. CURRENTLY, PATIENT HAS LOST MOST OF THE FLEXIBILITY IN HIS BACK AND NOW SUFFERS FROM A CONSIDERABLE INCREASE IN HIS OVERALL BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401035 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