BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2915721 · Received January 9, 2013

    Report

    Report Number
    MW5028520
    Date Received
    January 9, 2013
    Date of Event
    January 4, 2008
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SURGEON USED THE MEDTRONIC INFUSE WHICH CAUSED ME SIGNIFICANT PAIN AND HAS REQUIRED ME TO FREQUENTLY VISIT MY DOCTOR. I HAVE PERMANENT NERVE DAMAGE AND I'M CONSTANTLY WORRIED THAT THINGS WILL GET WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11102 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention| S