BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163314 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02196
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    December 15, 2017
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007, THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH STATUS POST ARTHRODESIS. MALFUNCTIONING INTERNAL ORTHOPEDIC DEVICE/GRAFT (NON UNION, L4-5). SPONDYLOLISTHESIS, L4-5. SPINAL STENOSIS, L4-5 AND UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR SPINAL FUSION, L4-5 (REVISION SURGICAL FIELD). POSTERIOR INTERBODY FUSION, L4-5 (REVISION SURGICAL FIELD). REMOVAL NON SEGMENTAL INSTRUMENTATION. EXPLORATION SPINAL FUSION. NON SEGMENTAL INSTRUMENTATION, L4-5 , APPLICATION OF VERTEBRAL BODY MECHANICAL DEVICE, L4-5. EXTRA FACET TRANSFORAMINAL APPROACH, L4-5. LAMINOTOMY RE-EXPLORATION, L4-5. LOCAL BONE GRAFT. ALLOGRAFT ( RHBMP2) FLUOROSCOPY. FINDINGS OF SURGERY: NON-UNION, L4-5, LOOSE HARDWARE, L4-5. EPIDURAL FIBROSIS AND PERINEURAL SCARRING L4-5. SPONDYLOLISTHESIS L4-5. AS PER OP-NOTES,¿ THERE WAS NO EVIDENCE OF SOLID FUSION. THERE WAS GROSS MOTION AT THE L4-5 LEVEL. EXTRA FACET DECOMPRESSION WITH REMOVAL OF FACET JOINT AT L4-5 WAS THEN UNDERTAKEN ON THE LEFT. THIS WAS THROUGH A REVISION SURGICAL FIELD. SUBTOTAL FACETECTOMY WAS COMPLETED AND NEUROFORAMEN WAS DECOMPRESSED METICULOUSLY. THE INTERVERTEBRAL DISC WAS IDENTIFIED. SUBTOTAL DISCECTOMY WAS THEN UNDERTAKEN THROUGH THE NEUROFORAMEN. UPON COMPLETION OF SUBTOTAL DISCECTOMY AND DEBRIDEMENT OF ALL SOFT TISSUE FROM THE END PLATES AT THE CENTRAL AND ANTERIOR PORTION OF THE DISC, AN APPROPRIATE SIZE CAGE WAS FILLED WITH RHBMP2 AND IMPACTED AND ROTATED UNTO POSITION AT THE L4-5 INTERSPACE. AN ADDITIONAL LOCAL BONE WAS PLACED POSTERIOR TO THE CAGE. LARGER SCREWS IN DIAMETER AND LONGER SCREWS WERE THEN PLACED AT THE L4-5 LEVEL. TIEI DID NOTE THAT THE PANT HAS OSTEOPOROSIS AND IT WAS DIFFICULT TO ACHIEVE ADEQUATE SCREW PURCHASE. FOR THAT REASON I AM VERY CONCERNED ABOUT THE POSSIBILITY OF NON UNION IN SPITE OF INTERBODY AND POSTERIOR REVISION FUSION. THE SCREW S WERE THEN PLACED ON THE RIGHT SIDE AT L4-5 UNDER FLUOROSCOPIC GUIDANCE.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. (B)(6) 2007: THE PATIENT WAS DISCHARGED FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264459 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M115005AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other