BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BMP

    MDR report key: 2994306 · Received March 2, 2013

    Report

    Report Number
    MW5029246
    Event Type
    Injury
    Date Received
    March 2, 2013
    Date of Event
    January 16, 2009
    Report Date
    March 2, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD MULTI-LEVEL CERVICAL FUSION AND DISKECTOMY AND FORAMINOTOMY PERFORMED BY SPINE SURGEON AT (B)(6) UTILIZING INTERBODY SPACER AND BMP. I HAD POST-OPERATIVE SWELLING, HOARSENESS AND CHOKING. SEVERAL MONTHS LATER MY SYMPTOMS GREW WORSE, PAIN IN MY NECK, HANDS, LEGS AND WAS SO SEVERE I HAD F/U REMEDIAL SURGERY WHEN IMAGING REVEALED BONE GROWTH COMPRESSING MY SPINAL CANAL. SO I HAD A C4-7 LAMINECTOMY WITH INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90565 INFUSE BMP INFUSE NEK MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Disability