BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2801868 · Received October 23, 2012

    Report

    Report Number
    1030489-2012-01935
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TWO LEVEL ANTERIOR CERVICAL INTERBODY FUSION AT C4/5 AND C5/6 USING ANTERIOR CERVICAL PLATING AND PEEK SPACERS PACKED WITH RHBMP-2/ACS. IT WAS CONFIRMED THAT THE PATIENT WAS "FREE FROM UNPLANNED RETAINED OBJECTS FOLLOWING SURGERY". POST-OPERATIVELY, IT IS ALLEGED THAT THE PATIENT HAD INTENSE PAIN IN NECK, BACK, LEGS, ARMS AND HANDS, NUMBNESS, HOARSE VOICE, AND OCCASIONAL SHORTNESS OF BREATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110901AAI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PEEK INTERBODY DEVICE, ANTERIOR CERVICAL PLATING