BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3192872 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02574
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    September 26, 2016
    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 ON (B)(6) 2004, PATIENT UNDERWENT AN L4-L5 FUSION INVOLVING RHBMP-2/ACS. SURGEON UTILIZED A COMBINATION OF ANTERIOR AND POSTERIOR APPROACH AND MIXED RHBMP-2/ACS WITH ALLOGRAFT. PATIENT WAS DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. AS A RESULT, PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. PATIENT HAS NEVER RECOVERED FROM HIS SURGERY INVOLVING RHBMP-2/ACS, AND HE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2004, PATIENT UNDERWENT FOLLOWING PROCEDURE: ANTERIOR EXPOSURE FOR L4-5 SPINAL FUSION. PRE-OP AND POST-OP DIAGNOSIS: ON (B)(6) 2004, PATIENT UNDERWENT FOLLOWING PROCEDURE: ANTERIOR LUMBAR INTERBODY FUSION WITH ALLOGRAFT AND BONE MORPHOGENIC PROTEIN. PRE-OP AND POST-OP DIAGNOSIS: SPONDYLOLISTHESIS L4-5, STATUS POST FUSION L5-S1. LUMBAR INSTABILITY L4-5. SPINAL STENOSIS L4-5 LATERAL RECESS STENOSIS. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293445 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111003AG

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention