BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT DEVICE (PH BMPZ)

    MDR report key: 3088645 · Received April 29, 2013

    Report

    Report Number
    MW5030005
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    August 22, 2008
    Report Date
    April 9, 2013
    Manufacturer
    METRONIC INC
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD TWO OFF LABEL SURGERIES WITH INFUSE, WHICH RESULTED IN HETEROTOPIC BONE GROWTH AT L4, L5 AND L5, S1. CAUSING ON GOING BACK AND LEG PAIN WITH NUMBNESS AND BURNING CONSTANTLY. OSTEOLYSIS AT L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184217 INFUSE BONE GRAFT DEVICE (PH BMPZ) INFUSE NEK METRONIC INC
    184218 INFUSE BONE GRAFT DEVICE (PH BMPZ) INFUSE NEK METRONIC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R| S