BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITOSS FOAM PACK

    MDR report key: 839428 · Received April 17, 2007

    Report

    Report Number
    2530131-2007-00001
    Event Type
    Injury
    Date Received
    April 17, 2007
    Date of Event
    March 13, 2007
    Report Date
    April 17, 2007
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    LYC
    PMA / PMN Number
    k032288
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VITOSS FOAM PACK DEVICE HISTORY RECORD WAS REVIEWED FOR LOT # B612018. ALL MATERIAL PROPERTIES AND MANUFACTURING PARAMETERS WERE WITHIN SPECIFIED LIMITS. (REFERENCE METHOD NOTED). THE LIKELY CAUSE OF THIS EVENT IS THE INTRODUCTION OF AIR INTO THE VASCULATURE OF THE SACRUM WHICH IS COINCIDENT WITH THE INTRODUCTION OF THE BONE GRAFT MATERIAL. THE HYPOTENSIVE EFFECTS OF AIR EMBOLI IS WELL UNDERSTOOD (ANESTHESIOLOGY 2007). VITOSS FOAM PACK, ONCE WETTED WITH BLOOD, MARROW OR SALINE EXHIBITS THE CONSISTENCY OF A PUTTY. THERE ARE OTHER GRAFT MATERIALS SUCH AS CERTAIN DEMINERALIZD BONE MATRICES WHICH ALSO ARE PUTTY-LIKE. ANY PUTTY-LIKE MATERIAL PLACED IN THE BONE GRAFT INTRODUCER (ESSENTIALLY A HOLLOW METAL TUBE) WOULD TEND TO OCCLUDE THE LUMEN OF THE TUBE. SUBSEQUENTLY, ANY AIR IN FRONT OF THE GRAFT MATERIAL (AS THE BONE GRAFT MATERIAL IS PLACED IN THE TUBE) WOULD BE TRAPPED AND THEN DISPLACED INTO THE DISC SPACE AND ALSO THE CANCELLOUS BONE OF THE SACRUM AS THE BONE GRAFT IS ADVANCED FORWARD IN THE TUBE. THE FASTER THE MATERIAL IS INTRODUCED , THE MORE THE AIR WILL BE PRESSURIZED, INCREASING THE LIKELIHOOD OF AIR ENTERING THE VESSELS OF THE SACRUM. IT IS OUR BELIEF THAT THIS MAY HAVE HAPPENED IN THIS INSTANCE. REFER TO TRANS1'S MFR REPORT #3004578806-2007-00011.

    Description of Event or Problem · 1

    IN 2007, A DISTRIBUTOR REPORTED TO ORTHOVITA A POTENTIAL PROBLEM WITH THE USE OF VITOSS FOAM PACK IN FOUR PATIENTS WHO UNDERWENT SPINAL FUSION PROCEDURES USING THE TRANS1 AXIALIF INSTRUMENTATION SYSTEM. THE TRANS1 AXIALIF PROCEDURE USES A PERCUTANEOUS APPROACH ANTERIOR TO THE SACRUM, ACCESSING THE BONE AT S1, AND THE CONTINUES ON INTO THE BODY OF L5. FOLLOWING ACCESS TO THE DISC SPACE OF L5-S1, THE DISC IS REMOVED AND A FIRST QUANTITY OF BONE GRAFT INTRODUCED. THEN THE AXIAL ROD IS INTRODUCED WHICH DISTRACTS THE DISC SPACE AND PROVIDES FIXATION. MORE BONE GRAFT IS INTRODUCED THROUGH THE CANNULATED AXIAL ROD AFTER DISTRACTION. FOUR PATIENTS TREATED BY THREE SURGEONS OVER A PERIOD OF FOUR DAYS, EACH EXHIBITED A SIGNIFICANT DROP IN BLOOD PRESSURE AT THE TIME THE VITOSS FOAM PACK WAS DELIVERED TO THE DISC SPACE. WITH APPROPRIATE MEASURES BY THE ANESTHETIST EACH OF THE PATIENTS WAS HEMODYNAMICALLY STABILIZED AND SUFFERED NO PERMANENT CONSEQUENCES. THIS REPORT DEALS SPECIFICALLY WITH PATIENT 1 OF 4. THIS EVENT OCCURRED ON THE EVENT DATE. THE SURGEON WAS DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITOSS FOAM PACK BONE GRAFT MATERIAL LYC ORTHOVITA, INC. NA B612018

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention TRANS1 AXIALIF SYSTEM, MANUFACTURED BY TRANS1