BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4152869 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03938
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    December 12, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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, ON (B)(6) 2010, PATIENT UNDERWENT FOLLOWING PROCEDURE: CORTICAL SCREW PLACEMENT, L4, L5, S1. POSTERIOR LUMBAR INTERBODY FUSION, LEFT L4-5, L5-S1 WITH PEEK CAGE. POSTEROLATERAL FUSION L4-5, L5-S1. SEGMENTAL FIXATION OF L4-5, L5-S1. AUTOLOGOUS BONE GRAFT. INTRAOPERATIVE SSEP MONITORING AND EMG MONITORING. INTRATHECAL INJECTION OF MORPHINE PRE-OP AND POST-OP DIAGNOSIS: LUMBAR DISC DISEASE. LOW BACK PAIN. LUMBAR RADICULOPATHY AS PER OPERATIVE NOTES: ".. AT L5-S1, DISC SPACE WAS THEN IRRIGATED WITH COPIOUS AMOUNTS OF ANCEF AND THEN A FUNNEL WAS THEN USED TO INTRODUCE MORSELIZED BONE GRAFT ALONG WITH BONE MORPHOGENIC PROTEIN INTO THE ANTERIOR DISC SPACE. THIS WAS FOLLOWED WITH A PEEK CAGE AFTER USING TRIALS TO DETERMINE APPROPRIATE SIZING. IDENTICAL PROCEDURE WAS UNDERTAKEN ON THE LEFT AT L4-5. SATISFACTORY POSITION OF THE IMPLANTS WAS NOTED IN THE LATERAL C-ARM FLUOROSCOPY. I THEN PROCEEDED TO CONTOUR RODS, ATTACHED THEM TO THE HEADS OF THE SCREWS AT L4, L5 AND S1. THE LATERAL GUTTERS WERE CREATED WITH A HIGH SPEED 5MM DRILL. A BURRITO OF BONE MORPHOGENIC PROTEIN COLLAGEN SPONGE AND AUTOLOGOUS BONE GRAFT WAS PLACED OVER THE POSTEROLATERAL ELEMENTS.. PATIENT WAS TAKEN TO RECOVERY ROOM IN SATISFACTORY CONDITION.." ON (B)(6) 2010, PATIENT UNDERWENT FOLLOWING PROCEDURE: REPOSITIONING OF RIGHT L4 CORTICAL SCREW. PRE-OP AND POST-OP DIAGNOSIS: RIGHT LUMBAR RADICULOPATHY AND MALPOSITIONED SCREW, RIGHT L4. PER-OPERATIVE NOTES: ".. A SHARP INCISION WAS MADE THROUGH THE HEALING LUMBAR WOUND MIDLINE INCISION.. SEROMA WAS IDENTIFIED THAT APPEARED NON-PURULENT IN NATURE. CAPS OF CORTICAL SCREWS WERE THEN REMOVED AND THE ROD REMOVED. THE RIGHT L4 SCREW WAS THEN REMOVED AND A MEDIAL BREACH IN THE WALL WAS IDENTIFIED. I THEREFORE, REPOSITIONED THE ENTRY POINT 4MM LATERALLY AND MORE CEPHALAD USING LATERAL C-ARM FLUOROSCOPY FOR PURPOSES OF IDENTIFICATION AND TRAJECTORY.. THE ORIGINAL SCREW WAS THEN REPOSITIONED IN THIS NEW TRAJECTORY. THE ROD WAS THEN REATTACHED TO THE THREE SCREW HEADS AND THE CAPS WERE TIGHTENED TO THE USUAL TORQUE TIGHTNESS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTEROLATERAL LUMBAR FUSION AT L4-5, L5-S1 USING RHBMP-2/ACS. FOLLOWING THE SURGERY, THE PATIENT HAD SIGNIFICANT PAIN IN THE AREA OF THE FUSION SURGERY AND EXTREMITIES. THE PATIENT UNDERWENT ADDITIONAL IMAGING THAT SHOWED THAT THE PATIENT HAD DEVELOPED BONEY OVERGROWTH. THE PATIENT HAS RECEIVED SIGNIFICANT MEDICAL TREATMENT TO CARE FOR THE INJURIES CAUSED BY THE ORIGINAL FUSION SURGERY. THE PATIENT HAS NEVER RECOVERED FROM HIS SURGERY, AND HE HAS DAILY, DISABLING PAIN THAT PREVENTS HIM FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630423 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110809AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R