BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC INFUSE BONE GRAFT DEVICE (RHBMP-2)

    MDR report key: 3030382 · Received March 28, 2013

    Report

    Report Number
    MW5029556
    Date Received
    March 28, 2013
    Date of Event
    April 26, 2010
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, I UNDERWENT BACK FUSION SURGERY ON MY L4-L5 LUMBAR DISCS USING MEDTRONIC INFUSE SYSTEM. THE MATERIAL OVERGREW INTO MY SPINE CAUSING NERVE COMPRESSION RESULTING IN PERMANENT NUMBNESS AND DEBILITATING PAIN IN MY LEFT LEG AND FOOT. I HAD TWO SURGERIES TO REMOVE OVERGROWTH OF FUSION MATERIAL. THE INFUSION MATERIAL FAILED TO FUSE AND THEREFORE LED TO ADDITIONAL SURGERY TO REFUSE THE DISCS. BEFORE SURGERY I HAD NO PAIN IN MY LOWER BACK AND NOW IT IS EXTREMELY PAINFUL TO STAND OR SIT FOR OVER 20 MINUTES AND I CAN NOT WALK MORE THAN 20 FEET WITHOUT STOPPING DUE TO BACK PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129716 MEDTRONIC INFUSE BONE GRAFT DEVICE (RHBMP-2) INFUSE BONE GRAFT NEK MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R| S