BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE GRAFT OR RHBMP2

    MDR report key: 2926119 · Received January 17, 2013

    Report

    Report Number
    MW5028659
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 27, 2006
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SURGEON USED THE MEDTRONIC INFUSE DURING MY SPINAL SURGERY WHICH CAUSED ME SIGNIFICANT PAIN, REQUIRED ME TO FREQUENTLY FOLLOW-UP WITH MY DOCTOR AS WELL AS NEED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26325 MEDTRONIC INFUSE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R