BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT DEVICE (RHBMP2)

    MDR report key: 3030402 · Received March 28, 2013

    Report

    Report Number
    MW5029555
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    June 18, 2008
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ECTOPIC BONE GROWTH DUE TO INFUSE. CAUSING SEVERE BACK PAIN, REQUIRING REVISION SURGERY. REASON FOR USE: SCOLIOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129661 INFUSE BONE GRAFT DEVICE (RHBMP2) INFUSE NEK MEDTRONIC INC.
    129662 INFUSE BONE GRAFT DEVICE (RHBMP2) INFUSE NEK MEDTORNIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O| R| S