BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3894033 · Received June 25, 2014

    Report

    Report Number
    1030489-2014-02895
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    February 23, 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)(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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTEROLATERAL FUSION SURGERY FROM L4 TO S1 ON (B)(6) 2011 USING RHBMP-2/ACS. THE RHBMP-2/ACS WAS PLACED IN THE LATERAL GUTTERS. SOMETIME POSTOP, THE PATIENT REPORTEDLY EXPERIENCED BURNING PAIN THAT SHOOTS DOWN BOTH LEGS. THE PATIENT CONTINUES TO EXPERIENCE SEVERE AND UNRELENTING BACK PAIN AND ASSOCIATED NUMBNESS THAT RADIATES INTO HER LOWER EXTREMITIES. SHE HAS DIFFICULTY URINATING AS WELL AS TROUBLE WALKING FOR EXTENDED PERIODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370981 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111064AAO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other