BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT DEVICE (RHBMP-2)

    MDR report key: 3060221 · Received April 10, 2013

    Report

    Report Number
    MW5029753
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    June 1, 2005
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2005: LEFT LATERAL FUSION OF L1, L2 AND L3 USING INFUSE. SEVERE PAIN WITHIN TWO WEEKS FOLLOWING SURGERY. WAS HOSPITALIZED AND BY (B)(6) WAS DIAGNOSED WITH ERYTHEMA NODOSUM, AN EXTREME INFLAMMATORY REACTION. PLATELETS INCREASED "10 1, 000, 000". LEFT LEG HAS PERMANENT NERVE DAMAGE. HEMATOLOGIST SAID IT COULD POSSIBILITY BE AN ALLERGIC REACTION TO INFUSE DUE TO MY AUTOIMMUNE SPHEROCYTOSIS. PRIOR TO MY (B)(6) 2011 BACK SURGERY, THE SURGEON STATED I NEEDED ANOTHER SURGERY DUE TO INCREASED STENOSIS L4-L5 VALIDATED BY AN MRI. I TOLD HIM I FELT I HAD A REACTION TO INFUSE FROM MY (B)(6)2005 SURGERY. HE HAD NEVER HEARD OF SUCH A THING AND SAID HE WOULD USE INFUSE. ONE MONTH FOLLOWING THE SURGERY I EXPERIENCED SIGNIFICANT PAIN AND LEG SPASMS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149272 INFUSE BONE GRAFT DEVICE (RHBMP-2) INFUSE NEK MEDTRONIC INC.
    149273 INFUSE BONE GRAFT DEVICE (RHBMP-2) INFUSE NEK MEDTORNIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R| S