BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3421117 · Received October 21, 2013

    Report

    Report Number
    1030489-2013-04197
    Event Type
    Injury
    Date Received
    October 21, 2013
    Report Date
    September 17, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 ON (B)(6) 2007, THE PATIENT WAS ADMITTED FOR POSTERIOR INTERBODY FUSION L4-5 TO L5-S1 WITH POSTEROLATERAL INSTRUMENTED FUSION L4 TO S1; INSTRUMENTATION WITH BILATERAL LAMINECTOMY FORAMINOTOMY L4 TO S1. THE PATIENT HAD SEVERE LOW BACK AND RADIATING LEG PAIN. HE IS KNOWN TO HAVE SPONDYLOLISTHESIS WITH DISK HERNIATIONS FROM L4 TO S1. HE FAILED NONOPERATIVE MANAGEMENT. AN L5-S1 LAMINECTOMY WAS PERFORMED AND THERE WERE FOUND TO BE BILATERAL PARS DEFECTS AND THESE WERE IDENTIFIED AND DECOMPRESSED. AFTER DECOMPRESSION, THE NERVE ROOTS WERE PROBED WITH A BALL TIPPED PROBE AND FOUND TO BE FREE OF COMPRESSION. A DISKECTOMY WAS THEN PERFORMED USING 15 SCALPEL FOLLOWED BY PITUITARY RONGEURS, CURETTES AND SHAVERS. AFTER A COMPLETE DISKECTOMY HAD BEEN PERFORMED, THE END PLATED WERE DECORTICATED WITH AN OSTEOTOME. THE DISK SPACE WAS IRRIGATED WITH STERILE SALINE. THE DISK WAS PACKED WITH LOCAL BONE GRAFT FOLLOWED BY A PEEK CAGE PACKED WITH RHBMP-2/ACS SPONGE. THIS WAS INSERTED AND WAS FELT TO HAVE GOOD POSITION AND STABILITY. ANTERIOR, POSTERIOR AND LATERAL C-ARM IMAGES WERE TAKEN TO VERIFY GOOD POSITION OF THE CAGES AND SCREWS. THE INCISION WAS IRRIGATED WITH STERILE SALINE FOLLOWED BY ANTIBIOTIC IRRIGATION. THE TRANSVERSE PROCESSES WERE DECORTICATED FROM L4 TO S1 USING RONGEURS AND AN OSTEOTOME. LOCAL BONE GRAFT WAS MORSELIZED AND PACKED FROM L4 TO S1 BILATERALLY. BONE MORPHOGENIC PROTEIN SPONGES WERE PACKED WITH BONE GRAFT AND PLACED FROM L4 TO S1 BILATERALLY. GOOD FUSION WAS CREATED BILATERALLY. TITANIUM RODS WERE PLACED ON THE SCREWS AND TIGHTENED DOWN USING LOCKING INSTRUMENTS. AFTER FINAL TIGHTENING, IT WAS FELT THERE WAS GOOD STABILITY FROM L4 TO S1. THE PATIENT HAD TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2008, THE PATIENT WAS ADMITTED FOR LAMINECTOMY AND DECOMPRESSION L4-L5 WITH EXPLORATION OF FUSION AND HARDWARE REMOVAL. THE PATIENT, WITH A DIAGNOSIS OF PSEUDOARTHROSIS L4 TO S1 WITH SPINAL STENOSIS, WAS FOUND TO HAVE LOOSENING OF THE L4 SCREWS AND POSTERIOR MIGRATION OF THE L4-L5 CAGE. THE PATIENT UNDERWENT HARDWARE REMOVAL L4 TO S1, WITH LAMINECTOMY, FORAMINOTOMY AND REVISION OF INSTRUMENTATION; POSTERIOR INSTRUMENTED FUSION L4 TO S1 WITH LANX INSTRUMENTATION. DURING THE PROCEDURE, IT WAS NOTED THAT RHBMP-2/ACS SPONGES WERE PACKED WITH BONE GRAFT AND PLACED FROM L4 TO S1 BILATERALLY. A GOOD FUSION BED WAS CREATED BILATERALLY. POST-PROCEDURE, THE PATIENT WAS FOUND TO HAVE TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2013, THE PATIENT WAS ADMITTED FOR ANTERIOR CERVICAL DECOMPRESSION WITH FUSION, C5-C6, WITH PLACEMENT OF MOSS CAGE AND LANX PLATE. THE PATIENT WAS FOUND TO HAVE A HERNIATED DISK AT THE C5-6 LEVEL. HE HAD FAILED NONOPERATIVE MANAGEMENT AND PRESENTED FOR OPERATIVE DECOMPRESSION AND FUSION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537574 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110608AAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other