BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1980165 · Received February 2, 2011

    Report

    Report Number
    MW5019255
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    October 2, 2007
    Report Date
    January 25, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FUSION OF L5-S1 USING MEDTRONIC SURGERY SPINAL INFUSE (BMP.2) AS THE FUSION MEDIA. WITHIN 2 WEEKS, I STARTED TO HAVE SEVERE LEG PAIN (I HAD NO LEG PAIN PRIOR TO SURGERY) AND BACK PAIN. I WENT ON TO HAVE 3 MORE SURGERIES ((B)(6) 2007, (B)(6) 2009 AND (B)(6) 2010). NONE OF THESE PROCEDURES ENDED THE PAIN. THE SURGERY ON (B)(6) 2009 REPLACED COMPLETELY ALL HARDWARE AND MEDIA. MEDIA USED IN (B)(6) 2009 SURGERY WAS A CORAL BASED PRODUCT. NEUROSURGEON -(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INFUSE NEK MEDTRONIC BMP.2

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability