BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMBAR INTERBODY FUSION SYSTEM

    MDR report key: 619372 · Received July 1, 2005

    Report

    Report Number
    2184052-2005-00005
    Event Type
    Other
    Date Received
    July 1, 2005
    Date of Event
    May 31, 2005
    Report Date
    June 30, 2005
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT SURGERY FOR BILATERAL LAMINECTOMY, A DISCECTOMY AND POSTERIOR IMPLANTATIN OF TWO 11 X 24 MM BAK VISTA RADIOLUCENT FUSION CAGES, LOT# P032329) WITH POSTEROLATERAL ONLAY FUSION UTILIZING AUTOGRAFT, ALLOGRAFT AND DEMINERALIZED BONE MATRIX PUTTY (BMP) WITH GPS SPRAY. GPS SPRAY IS THE PATIENT'S OWN BLOOD THAT HAS BEEN SPUN DOWN/SEPARATED AND THE PLASMA PORTION HAS BEEN SAVED FOR MIXING WITH THE BMP ALLOGRAFT MATERIAL. IN OCT. 2004, THE PATIENT BEGAN HAVING CLEAR FLUID DRAINAGE FROM THE SITE OF INCISION AND WAS PLACED ON ORAL ANTIBIOTICS. PATIENT WAS READMITTED TO HOSPITAL FOR DRAINAGE AND APPLICATION OF WOUND VAC AND WAS RELEASED FROM THE HOSPITAL ON HOME IV ANTIBIOTICS FOR SEVERAL WEEKS. IN MAY 2005, PATIENT WAS DIAGNOSED WITH A DISPLACED BAK VISTA CAGE ON THE PATIENT'S RIGHT SIDE. PATIENTS WAS ADMITTED TO THE HOSPITAL FOR REMOVAL OF THE CAGE ON THE PATIENT'S RIGHT SIDE. THE LEFT CAGE WAS NOT REMOVED AS IT WAS FUSED INTO PLACE. THE VOID LEFT BY THE RIGHT SIDE CAGE WAS FILLED WITH AUTOGRAFT BONE AND BMP. STABILIZATION WAS PROVIDED BY IMPLANTATION OF A SINGLE LEVEL, BILATERAL POSTERIOR PEDICLE SCREW AND ROD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR INTERBODY FUSION SYSTEM BAK VISTA RADIOLUCENT DEVICE MAX ZIMMER SPINE, INC. NA P032329

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization