BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE GRAFT OR RHBMP2

    MDR report key: 2840010 · Received November 15, 2012

    Report

    Report Number
    MW5027686
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    May 28, 2005
    Report Date
    October 31, 2012
    Manufacturer
    MEDTORNIC, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SURGEON USED THE MEDTRONIC INFUSE ON MY BACK DURING SURGERY WHICH HAS CAUSED ME SIGNIFICANT PAIN & PHYSICAL LIMITATIONS. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE. ON (B)(6) 2012, HAD ADDITIONAL SURGERY DUE TO PINCHED NERVES AT L-3, L-4, AND L-5 ACCORDING TO DR. (B)(6), SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INFUSE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTORNIC, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention