BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4152872 · Received October 8, 2014

    Report

    Report Number
    1030489-2014-03932
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH: LOW BACK PAIN. LUMBAR RADICULOPATHY. PATIENT UNDERWENT FOLLOWING PROCEDURES: L4 FAR LATERAL DECOMPRESSIVE LAMINECTOMY WITH BILATERAL MEDIAL FACETECTOMY AND FORAMINOTOMY COMPLETELY DECOMPRESSING THE THECAL SAC AND NERVE ROOT. L5 FAR LATERAL DECOMPRESSIVE LAMINECTOMY WITH BILATERAL MEDIAL FACETECTOMY AND FORAMINOTOMY COMPLETELY DECOMPRESSING THE THECAL SAC AND NERVE ROOT. S1 FAR LATERAL DECOMPRESSIVE LAMINECTOMY WITH BILATERAL MEDIAL FACETECTOMY AND FORAMINOTOMY COMPLETELY DECOMPRESSING THE THECAL SAC AND NERVE ROOT. POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5 AND L5-S1. POSTEREOLATERAL ARTHRODESIS AT L4-L5 AND L5-S1. PLACEMENT OF INTERBODY AT HAS PROSTHETIC DEVICE AT L4-L5 AND L5-S1. PEDICLE SCREW FIXATION USING SINTA BIOTECH PEDICLE SCREW, MRI COMPATIBLE. PLACEMENT OF AUTOGRAFT MORCELLIZED BONE HARVESTING WITH BONE MORPHOGENIC PROTEIN AND GENEX FOR POSTEROLATERAL ARTHRODESIS. AS PER-OP NOTES, ¿USING THE TECHNIQUE OF IDENTIFYING THE MAMMILLARY PROCESS, DRILL, GEARSHIFT TAP, 7.0 X 50MM SCREWS WERE PLACED AT S1 BILATERALLY. TWO RODS WERE CONTOURED INTO PLACE AND SET CAPS WERE USED, THEY WERE TORQUED AT THE APPROPRIATE LEVEL. TWO CROSS SPACE, CROSS CONNECTORS WERE ALSO USED. THE POSTEROLATERAL ARTHRODESIS WAS COMPLETED USING THE BONE MORPHOGENIC PROTEIN, GENEX, AS WELL AS HARVESTED AUTOGRAFT. AFTER CONFIRMING INSTRUMENTATION ON AN X-RAY, THE MUSCLE AND FASCIA WERE CLOSED¿¿ NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR 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 AND CAGE MIGRATION. 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
    630424 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 59 YR Required Intervention