BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3892522 · Received June 24, 2014

    Report

    Report Number
    1030489-2014-02870
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 28, 2018
    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)(6). (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 FUSION PROCEDURE FROM L4 TO S1 USING RHBMP-2/ACS ON (B)(6) 2011. PATIENT'S POST-OPERATIVE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE PAIN AND WEAKNESS IN HIS LOW BACK AND LOWER EXTREMITIES. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CT SCAN ON (B)(6) 2013, REVEALING NEUROCOMPRESSIVE LESIONS AT THE IMPLANT SITE. PATIENT'S CONDITION NECESSITATED REVISION SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING PAIN IN HIS BACK AND LOWER EXTREMITIES. HE SUFFERS FROM INCONTINENCE, IS UNABLE TO SIT OR STAND FOR LONG PERIODS, AND HIS SLEEP IS DISTURBED. IT WAS REPORTED THAT THE PATIENT IS PREVENTED FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE HE ENJOYED PRE-OPERATIVELY, AND HE HAS OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367789 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention