BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONEGRAFT

    MDR report key: 2973854 · Received February 20, 2013

    Report

    Report Number
    MW5029029
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    February 29, 2012
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY ON (B)(6) 2012 FOR HERNIATED DISC DUE TO A MVA. PT STATES THAT SHE STARTED TO HAVE SEVERE PAIN, NECK , SPINE, SHOULDERS AND HEAD, DYSPHAGIA AND NUMBNESS IN HER HEAD, LIPS, AND ARMS. PT DOCTOR SAID SHE NEEDED PAIN MANAGEMENT. PAIN MANAGEMENT STATES PT IS "TOO COMPLICATED".PT STATES SHE WANTS THE PRODUCT REMOVED BUT DOES KNOW WHO TO CONTACT. PT SAYS 2 MEDTRONIC REPS WERE PRESENT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74339 INFUSE BONEGRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN NEK MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR