BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3884990 · Received June 19, 2014

    Report

    Report Number
    1030489-2014-02826
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    September 12, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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 THE PATIENT UNDERWENT A POSTERIOR INTERBODY FUSION AT L3-L4 IN WHICH RHBMP-2/ACS AND A PEEK FUSION CAGE WERE USED. THE CAGE WAS PACKED WITH BMP. POSTOPERATIVELY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED RADIATING PAIN TO HIS LEGS. REPORTEDLY, THE PATIENT EXPERIENCES DAILY, 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) 2008: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH ADJACENT LEVEL DISEASE L3-L4 RESULTING IN SPINAL STENOSIS. SPINAL LUMBAR FUSION, L4 TO S1 AND UNDERWENT THE FOLLOWING PROCEDURES: L2-L4 DECOMPRESSIVE LAMINECTOMY. L3-L4 POSTERIOR LUMBAR INTERBODY FUSION USING BIOMECHANICAL FUSION DEVICE AND BMP. PEDICLE SCREW INSTRUMENTATION USING PEDICLE SCREW SYSTEM. REMOVAL OF POSTERIOR HARDWARE L4-S1. AS PER OP-NOTES, " I USED CIRCULATING CURETS TO SEQUENTIALLY REAM OUT AND PREPARE THE L3-L4 DISC SPACE FOR THE INTERBODY GRAFT. THE LAST CURET USED WAS A 13 MM PEEK BIOMECHANICAL FUSION DEVICE IN THE DISC SPACE WITH BMP WITHIN IT TO FACILITATE THE FUSION. I THEN POSITIONED THE GRAFT IN SUCH A WAY THAT IT SETTLED WITHIN THE DISC SPACE IN AN EXCELLENT POSITION." THE PATIENT TOLERATED THE PROCEDURE WELL AND NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361899 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110710AAK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other