BEUDAMED
    FDA Adverse Event Summary report: N

    INFUSE BONE GRAFT DEVICE (RHBMP-2)

    MDR report key: 3040018 · Received April 3, 2013

    Report

    Report Number
    MW5029613
    Date Received
    April 3, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BONE OVER GROWTH. EXTREME INFLAMMATORY REACTION (B)(6) WKS AFTER (B)(6) 2011, INITIAL INFUSE SURGERY WITH NEW LEFT SIDE CONDITION EXTREME ELECTRICAL BURNING AND PAIN FROM L5-S1 TO FEET. REVISION SURGERY (B)(6) 2011 AFTER A CT MYELOGRAM. CHRONIC CSF LEAK FIRST NOTED BY ER DOCTORS WHILE TREATING A 60 DAY SEVERE SPINAL HEADACHE (B)(6) 2011. TRIAL SPINAL CORD STIMULATOR FAIL DUE TO CHRONIC CSF LEAK ON (B)(6) 2012. PERSISTENT CHRONIC RADICULITIS ACROSS L5-S1 TO BOTH LEFT AND RIGHT EXTREMITIES WITH PAINFUL, DECREASED RANGE OF MOTION WITH BURNING, STABBING, ELECTRICAL, TINGLING, NUMBNESS, 7-10 LEVEL PAIN. ALL SYMPTOMS WORSE THAN PRIOR SURGERY. SIGNIFICANT UPTAKE OF HEADACHE POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135608 INFUSE BONE GRAFT DEVICE (RHBMP-2) INFUSE NEK MEDTRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| S