BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 807425 · Received January 16, 2007

    Report

    Report Number
    807425
    Event Type
    Injury
    Date Received
    January 16, 2007
    Date of Event
    October 20, 2006
    Report Date
    January 3, 2007
    Manufacturer
    MEDTRONIC SAFAMER DANEK USA, INC.
    Product Code
    NEK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT C3 - C7 POSTEROLATERAL FUSION WITH MEDTRONIC INFUSE BONE GRAFT PRODUCT AND AUTOGRAFT, C3 - C7 BILATERAL LAMINECTOMY, MEDIAL FACETECTOMY, AND FORAMINOTOMY, C3-C7 BILATERAL MASS FUSION CONSTRUCT, WITH SUMMIT INSTRUMENTATION SYSTEM, DEPUY SPINE IN 2006. PATIENT DID WELL IMMEDIATELY POST OP, HOWEVER, ABOUT 36 HOURS POST OP, PATIENT EXPERIENCED PARALYSIS OF THE RIGHT ARM AND LEG AND NUMBNESS TO THE LEFT SIDE. PATIENT UNABLE TO STAND. MRI CONFIRMED SPINAL CORD COMPRESSION AND PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE A POST ILEOCERVICAL RE-EXPLORATION FOR EVACUATION OF AN EPIDURAL SEROMA AND REMOVAL OF THE INFUSE / BMP BONE GRAFT. ACCORDING TO THE OPERATIVE REPORT: FASCIA WAS OPENED COMPLETELY AND CAME ACROSS FLUID WHICH BEGAN TO OOZE OUT AND WAS UNDER SOME PRESSURE. THIS WAS SEROSANGUINOUS FLUID AND NOT HEMATOMA WAS NOTED. THIS FLUID WAS REMOVED AND IT APPEARED IT HAD NO WAY TO GO OUT GIVEN THE FASCIAL CLOSURE WAS FAIRLY TIGHT. THE CAL SAC WAS WELL DECOMPRESSED AND HEMOSTASIS WAS CONTROLLED. THE LEFT PARASPINAL MUSCLES WERE LIFTED AND THE INFUSE WHICH WAS WRAPPING THE AUTOGRAFT WAS REMOVED. PT HAD UNREMARKABLE POST OPERATIVE COURSE AND WAS DISCHARGED HOME WITH NO NEUROLOGICAL DEFICITS. PHYSICIAN REPORTS PATIENT HAS RECOVERED, HAS NO NEUROLOGICAL DEFICIT, AND HAS RETURNED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SAFAMER DANEK USA, INC. * M110601AAC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R