BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191443 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02555
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 30, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 SURGICAL PROCEDURE WHERE RHBMP-2/ACS WAS MIXED WITH MORSELIZED AUTOGRAFT AND ALLOGRAFT AND WRAPPED AROUND 60ML OF MASTERGRAFT MATRIX. THE MIXTURE WAS PLACED POSTERIORLY INTO L2-3, L3-4 AND L4-5. IN (B)(6) 2012, THE PATIENT DEVELOPED A VERY LARGE SEROMA IN HER LUMBAR SPINE. REPORTEDLY, THIS WAS AN INFLAMMATORY REACTION THAT NECESSITATED ANOTHER SURGERY. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT, INCLUDING HAVING TO UNDERGO ADDITIONAL SURGERIES. THE PATIENT HAS NEVER RECOVERED FROM HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291509 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 00057 YR Required Intervention