BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3192922 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02578
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    February 22, 2017
    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.

    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 ON (B)(6) 2012, THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE RHBMP-2/ACS WAS MIXED WITH ALLOGRAFT AND AUTOGRAFT AND WAS WRAPPED AROUND 10ML OF MASTERGRAFT MATRIX, AND PLACED OVER THE PATIENT¿S DECORTICATED SPINE FROM L1 TO L2, USING A POSTERIOR APPROACH. 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
    293605 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111059AAL

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention