BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3481324 · Received November 21, 2013

    Report

    Report Number
    1030489-2013-04618
    Event Type
    Injury
    Date Received
    November 21, 2013
    Report Date
    February 8, 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)(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 PRE-OPERATIVELY THE PATIENT WAS DIAGNOSED WITH GAIT DISTURBANCE, SCOLIOSIS, SPINAL STENOSIS, LATERAL FORAMINAL STENOSIS AND INTERVERTEBRAL COLLAPSE. PATIENT UNDERWENT A POSTERIOR TRANSVERSE PROCESS SPINAL FUSION, L4, L6, SI BILATERAL USING RHBMP-2/ACS AND DURAL REPAIR, LEFT L5-S1, WITH LAMINECTOMY AND RIGHT L6-S1 WITH LAMINECTOMY ON (B)(6) 2007. IT WAS REPORTED THAT POST-OPERATIVELY PATIENT HAD DURAL TEAR SECONDARY TO DEFECTIVE KERRISON RONGEUR. ON AN UNKNOWN DATE PATIENT'S P OST-OPERATIVE PERIOD WAS MARKED BY SEVERE, PAINFUL, AND DEBILITATING COMPLICATIONS WHICH INCLUDED, BUT WERE NOT LIMITED TO, THE NEED FOR ADDITIONAL SURGERY, PAINFUL MEDICAL TREATMENT, EXTREME PAIN, NERVE DAMAGE, NERVE IMPINGEMENT, AND SEVERE EXUBERANT, ECTOPIC BONE FORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007 THE PATIENT THE FOLLOWING PROCEDURES: POSTERIOR TRANSVERSE PROCESS SPINAL FUSION, L4, L5, S1 BILATERAL; INTERVER TEBRAL CAGE, L4-5, L5-S1; PEDICLE INSTRUMENTATION, L4, L5, S1 BILATERAL; TRANSFORAMINAL POSTERIOR INTERBODY FUSION, RIGHT L4-5, L5-S1; LEFT TRANSPEDICULAR NEURAL DECOMPRESSION, L5-S1; DURAL REPAIR, LEFT L5-S1, WITH LAMINECTOMY AND RIGHT L5-S1 WITH LAMIN ECTOMY; INTRAOPERATIVE RADIOLOGIC FLUOROSCOPIC DOCUMENTATION BY OPERATIVE TO TREAT THE FOLLOWING PRE-OP DIAGNOSIS: GAIT DIRSTURBANCE; SCOLIOSIS; SPINAL STENOSIS; LATERAL FORAMINAL STENOSIS; LNTERVERTEBRAL COLLAPSE. OP-NOTES: ¿..WE WERE DECORTICATING THIS AREA AND THEN PLACING CANCELLOUS AUTOLOGOUS BONE AND BONE. MORPHOGENETIC PROTEIN INTO THIS AREA FOR A POSTERIOR SPINAL TRANSVERSE PROCESS FUSION. THEN A STEINMAN PIN WAS PLACED OVER THE RIGHT SIDE OF L5 AND S1, SEQUENTIALLY ENLARGING CANNULAS TO A 26 MILLIMETER CANNULA WAS ACHIEVED, DIRECTING IT ANTERIORLY TO THE POSTERIOR MEDIAL ASPECT OF THE 4-5 AND S1 TRANSVERSE PROCESS MEDIALLY, DECORTICATING THIS AREA AT THIS VERY MEDIAL ASPECT POSTERIORLY, AND PLACING CANCELLOUS AUTOLOGOUS BONE AND BONE MORPHOGENETIC PROTEIN HARVESTED LOCALLY FOR A POSTERIOR SPINAL FUSION, TRANSVERSE PROCESS TECHNIQUE. AT THIS POINT THEN, AND HAVING DECOMPRESSED THIS AREA, THEN RESECTION THROUGH TRANSPEDICULAR TECHNIQUE OF THE ANNULUS NUCLEUS PULPOSUS THIS INTERCDISCAL DISTRACTION WAS ACHIEVED, AND END-PLATE RESECTION WAS ACCOMPLISHED AT THE 5-1 LEVEL, AND THEN PLACED CANCELLOUS AUTOLOGOUS BONE AND BONE MORPHOGENETIC PROTEIN IN THE ANTERIOR ASPECT OF THE DISC SPACE AT 5-1, AND THEN PLACED A CRESCENT IMPLANT MEASURING 13 X 26 IN THE INTERDISCAL SPACE AT L5-S1, FILLED WITH CANCELLOUS AUTOLOGOUS BONE AND BONE MORPHOGENEIC PROTEIN. DECORTICATING THE END-PLATES INTRADISCAL DISTRACTION WAS ACCOMPLISHED AND HELD BY THE CONTRALATERAL ROD SCREW CONSTRUCT, AND THEN IRRIGATED AND THEN CANCELLOUS AUTOLOGOUS BONE AND BONE MORPHOGENETIC PROTEIN WERE PLACED IN THE INTERDISCAL SPACE ON THE RIGHT SIDE AT L4-5, AND THEN A CAGE IMPLANT MEASURING 12 X 26 WAS PLACED FILLED WITH CANCELLOUS AUTOLOGOUS BONE AND BONE MORPHOGENETIC PROTEIN IN THE INTRADISCAL SPACE AT THE 4-5 LEVEL..¿ THE PATIENT WAS THEN EXTUBATED IN THE OPERATIVE SUITE AND RETURNED TO THE RECOVERY ROOM AWAKE AND NEUROVASCULARLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605058 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110603AAA

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Required Intervention