BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3192951 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02580
    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 THAT THE PATIENT UNDERWENT A POSTERIOR/POSTEROLATERAL L4-L5 FUSION USING RHBMP-2/ACS WITH A PEEK CAGE, AS WELL AS MIXING THE RHBMP-2/ACS WITH AUTOGRAFT AND DEMINERALIZED BONE MATRIX. IT WAS REPORTED THAT THE PATIENT WAS SUBSEQUENTLY DIAGNOSED WITH INJURIES INCLUDING ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO INFUSE, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REPORTED CONTINUED DAILY SEVERE DISABLING PAIN THAT PREVENTS HIM FROMPERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT: POSTERIOR LUMBAR INTERBODY FUSION, LEFT SIDE L4-5. POSTEROLATERAL ARTHRODESIS L4-5. POSTERIOR NON-SEGMENTAL INSTRUMENTATION L4-5. PLACEMENT OF INTERBODY CAGE AT L4-5. DECOMPRESSIVE LAMINECTOMY AT L4 WITH FACETECTOMIES AT L4-5 AND COMPLETE FORAMINOTOMIES , LEFT SIDE L4-5. LOCAL AUTOGRAFT HARVEST FROM SPINOUS PROCESSES AND LAMINAR FRAGMENTS. UTILIZATION OF INTRAOPERATIVE FLUOROSCOPY FOR DETERMINATION OF LEVELS AND PROPER PEDICLE SCREW PLACEMENT. PREOPERATIVE DIAGNOSIS; L4-5 FORAMINAL STENOSIS. L4-5 DEGENERATIVE DISC DISEASE. IMPLANTS: PEDICLE SCREWS AND PEEK ROD INSTRUMENTATION. INTERBODY CAGE AT L4-5 MEASURING 14MM IN HEIGHT. RHBMP-2/ACS SET. FIVE ML OF DEMINERALIZED BONE MATRIX. PER-OP NOTES: "THE REMAINING LAMINA AND TRANSVERSE PROCESSES WERE DECORTICATED WITH A 1/2 INCH CURVED OSTEOTOME TO OBTAIN ADEQUATE POSTEROLATERAL ARTHRODESIS. THE POSTEROLATERAL GUTTER WAS PACKED WITH BMP SPONGES AND LOCAL BONE AUTOGRAFT... A BMP SPONGE WAS INSERTED INTO THE ANTERIOR DISC SPACE FOLLOWED BY INSERTION OF THE PEEK INTERBODY CAGE. THIS WAS PLACED UNDER DIRECT VISUALIZATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293828 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention