BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2926120 · Received January 17, 2013

    Report

    Report Number
    MW5028660
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    February 8, 2011
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY SURGEON USED THE MEDTRONIC INFUSE WHICH CAUSED ME SIGNIFICANT PAIN, REQUIRED ME TO SEE A DOCTOR FREQUENTLY AFTER THE SURGERY AND REQUIRED ME TO UNDERGO A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25642 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention