BEUDAMED
    FDA Adverse Event Other Summary report: N

    6.5MM REVERE PEDICLE SCREW 45MM

    MDR report key: 906454 · Received August 30, 2007

    Report

    Report Number
    3004142400-2007-00007
    Event Type
    Other
    Date Received
    August 30, 2007
    Date of Event
    June 29, 2007
    Report Date
    August 29, 2007
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MCV
    PMA / PMN Number
    K061202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS/CONCLUSION: A FULL VISUAL INSPECTION WAS PERFORMED ON THE PARTS IN QUESTION. DURING THE PROCESS OF REMOVING THE SCREW SHAFTS THERE WAS NOTICEABLE DAMAGE TO THE SCREW. IT IS NOT POSSIBLE TO DETERMINE THE VALUE OF THE CRITICAL DIMENSIONS PRIOR TO THE REMOVAL. THE CRITICAL DIMENSIONS WOULD BE NECK DIAMETER AS WELL AS THE RADIUS OF THE TRANSITION FROM SCREW TO NECK DIAMETER AND NECK DIAMETER TO SPHERICAL HEAD. IT WAS SEEN THAT THE SCREW FRACTURED BELOW THE SPHERICAL HEAD PORTION OF THE SCREW. IT APPEARS THAT THE SCREWS ARE IN THE MOST ANGULATED STATE POSSIBLE. THE ANGULATION OF THE SCREW ASSISTS IN THE SURGERY OF THE SPINE BY ALLOWING THE SCREW TO ADJUST TO THE ANATOMY OF THE PT. THIS MAY INDICATE THAT THE SCREW WAS FORCED INTO A POSITION ABOVE ITS MAXIMUM ANGULATION DURING THE OPERATION AND CONTRIBUTED TO ITS FAILURE. THIS PT UNDERWENT A SPINAL FUSION AT THE L3-L4 LEVEL. THE PT WAS A FEMALE. THE AGE OF THE PT WAS NOT REPORTED TO GLOBUS MEDICAL. IN THIS CASE UNILATERAL SCREWS WERE PLACED WITH NO INTERBODY DEVICE FOR ANTERIOR COLUMN SUPPORT. PEDICLE SCREWS IN THIS TYPE OF CONSTRUCTION ARE DEPENDENT ON TO ENDURE EXTREMELY LARGE FORCES; IN SHEAR, COMPRESSION BENDING, AND PULLOUT. WHILE THE REVERE PEDICLE SCREWS CAN BE USED AS A UNILATERAL FIXATION DEVICE, THE WORST CASE TESTING THAT WAS PERFORMED FOR FDA APPROVAL UTILIZED FOUR SCREWS AND TWO RODS. IT CAN BE REASONABLY CONCLUDED THAT IN THIS CIRCUMSTANCE THE CLINICAL REQUIREMENTS EXCEEDED THE STRENGTH REQUIREMENTS OF THE SCREW AS SET FORTH IN THE PRODUCT DESIGN. THE LENGTH OF TIME FROM THE OPERATION TO THE REPORTED BREAKAGE WAS APPROXIMATELY 4 MONTHS. THIS PT MAY PRESENT UNK CIRCUMSTANCES THAT PROVIDE SIGNIFICANT STRESSES TO THE PEDICLE SCREWS. BIOMECHANICALLY IT IS KNOWN THAT A SIGNIFICANT AMOUNT OF STRESS IS PRESENT AT THE PEDICLE SCREW TO BONE INTERFACE. MUCH OF THE TRUNK WEIGHT IS BORNE BY THE LUMBAR SPINE. IT IS WELL DOCUMENTED IN THE LITERATURE THAT EVEN IN THE PRESENCE OF SOLID FUSION INSTRUMENTATION MAY BREAK OVER TIME. A SUMMARY ARTICLE IN THE JOURNAL OF BONE AND JOINT SURGERY TITLED "THE USE OF PEDICLE-SCREW INTERNAL FIXATION FOR THE OPERATIVE TREATMENT OF SPINAL DISORDERS", 2000; 82:1458, LISTS FIVE REFERENCES OF COMPLICATION OF PEDICLE SCREW FIXATION. THE SCREW BREAKAGE RATES RANGE FROM 2.6% TO 60%. UNDER THIS CONDITION THE LOADING MAY LEAD TO FAILURE. THE SCREW DESIGN WAS TESTED UNDER ALL APPLICABLE STANDARD TESTING AND DEEMED TO BE EQUAL OR GREATER IN STATIC AND FATIGUE STRENGTH TO OTHER DEVICES ON THE MARKET. FROM THIS INVESTIGATION IT IS INDETERMINATE AS TO WHAT SPECIFICALLY CAUSED THE SCREW TO FAIL, ALTHOUGH THERE IS NO EVIDENCE THAT THE SCREW WAS MANUFACTURED INCORRECTLY. IT CONCLUDED FROM THIS EVAL THAT THE COMBINATION OF PT ANATOMY AND CLINICAL USE OF THE PRODUCT LED TO A LESS THAN IDEAL OUTCOME.

    Description of Event or Problem · 1

    NOTE" GLOBUS MEDICAL, INC. WAS NOT AWARE IF THE FACILITY HAD SUBMITTED ANY MEDWATCH FORM FDA 3500A. THEREFORE, THE FOLLOWING "DESCRIBED EVENT OR PROBLEM" WAS TAKEN DIRECTLY OFF THE COMPLAINT PROCESSING FORM FROM GLOBUS MEDICAL, INC. 6.5MM REVERE PEDICLE SCREW 45 MM. "THIS SCREW BROKE INSIDE OF A FEMALE PT. THE PROCEDURE WAS POSTERIOR LATERAL FUSION WITH UNI-LATERAL SCREWS PLACED ON PTS RIGHT SIDE AT LEVEL L3-L4, WITH NO INTERBODY/GRAFT DEVICE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM REVERE PEDICLE SCREW 45MM PEDICLE SCREW MCV GLOBUS MEDICAL, INC. 124.465 GMG197KE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR