BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2896967 · Received December 19, 2012

    Report

    Report Number
    MW5028428
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    February 14, 2007
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC, INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SURGEON IMPLANTED THE MEDTRONIC INFUSE DURING MY SPINAL SURGERY. THIS HAS CAUSED ME MANY SERIOUS COMPLICATIONS INCLUDING SEVERE PAIN, THE NEED TO HAVE A FOLLOW UP SURGERY, AS WELL AS MENTAL ANGUISH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R