BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2903886 · Received January 4, 2013

    Report

    Report Number
    MW5028476
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    October 30, 2003
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE INFUSE IMPLANTED DURING MY SPINAL SURGERY, THIS HAS CAUSED ME MANY PROBLEMS AND HAS REQUIRED ME TO VISIT MY DOCTOR FREQUENTLY, AS WELL AS UNDERGO A REVISION SURGERY. I AM CONSTANTLY IN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5162 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R