BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3193030 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02584
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    October 17, 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.

    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 ON THAT THE PATIENT UNDERWENT AN ANTERIOR/POSTERIOR L4-S1 FUSION USING RHBMP-2/ACS, RAY CAGES, AND MIXING BMP WITH VITOSS BONE GRAFT AND AUTOGRAFT. IT WAS REPORTED THAT THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH INJURIES INCLUDING ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO BMP, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REPORTED CONTINUED DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2004 THE PATIENT UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION L4-5 AND L5-S1 WITH BONE MOPRHOGENIC PROTEIN USING FOUR 14MM CAGES, 2 AT EACH LEVEL. REMOVAL OF POSTERIOR L4, L5 AND S1 HARDWARE OF THE VARIETY. REDO POSTERIOR L4 TO S1 INSTRUMENTATION USING PEDICLE SCREWS. DIMENSIONS OF PEDICLE SCREWS AND RODS. PREOPERATIVE DIAGNOSIS: NON-UNION STATUS POST LUMBAR FUSION L4 THROUGH S1. PER-OP NOTES: THIS WAS FOLLOWED BY 14MM TAP ON BOTH SIDES FOLLOWED IN TURN BY IMPLANTATION OF THE 14MM BY 21MM DEEP CAGES THAT HAD BEEN FILLED WITH AUTOGRAFT AND BONE MORPHOGENIC PROTEIN. THE FRESHENED EDGES OF THE BONY NON UNION FROM L4 TO S1 WERE THEN CURETTED WITH AUTOGRAFT AS WELL AS BONE MORPHOGENIC PROTEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294201 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111003AL

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention