BEUDAMED
    FDA Adverse Event Other Summary report: N

    7.5MM REVERE PEDICLE SCREW 40MM

    MDR report key: 2957381 · Received August 23, 2007

    Report

    Report Number
    3004142400-2007-00013
    Event Type
    Other
    Date Received
    August 23, 2007
    Date of Event
    August 8, 2007
    Report Date
    August 22, 2007
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 PATIENT. THIS MAY INDICATE THAT THE SCREW WAS FORCED INTO A POSITION ABOVE ITS MAXIMUM ANGULATION DURING THE OPERATION AND CONTRIBUTED TO ITS FAILURE. THESE SCREWS WERE IMPLANTED IN THE SACRUM DURING A L5-S1 FUSION. THE PATIENT WAS REPORTED AS DOING WELL. DURING ONE OF HER FOLLOW UP VISITS SHE COMPLAINED OF A NEW PAIN HER BACK. THE LENGTH OF TIME FROM THE OPERATION TO THE REPORTED BREAKAGE WAS APPROXIMATELY 9 MONTHS. THIS PATIENT MAY PRESENT UNKNOWN CIRCUMSTANCES THAT PROVIDE SIGNIFICANT STRESSES TO THE PEDICLE SCREWS. BIOMECHANICALLY IT IS KNOWN THAT A SIGNIFICANT AMOUNT OF STRESS IS PRESENT WHEN ATTEMPTING TO FUSE L5 AND THE SACRUM. MUCH OF THE TRUNK WEIGHT IS BORNE BY THIS ANATOMICAL STRUCTURE. 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%. THIS MAY BE BECAUSE OF MICRO-MOTION LOADING IN THE VERTEBRAL BODIES. 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.

    Description of Event or Problem · 1

    NOTE: GLOBUS MEDICAL, INC. WAS NOT AWARE IF (B)(6) HOSPITAL IN (B)(6) 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. P/N (B)(4) 7.5MM REVERE PEDICLE SCREW 40MM. "ON (B)(6) 2006, DR. (B)(6) PERFORMED A L5-S1 POSTEROLATERAL FUSION UTILIZING THE REVERE SCREW SYSTEM. DR. SPANGLER IMPLANTED 2 - 6.5 X 45MM (124.465) SCREWS IN THE L5 PEDICLES AND 2 - 7.5X40MM SCREWS IN THE S1 PEDICLES. THE PATIENT HAD BEEN SEEN IN DR. (B)(6)S OFFICE AND WAS "DOING WELL". THE PATIENT RETURNED TO DR. (B)(6) OFFICE IN (B)(6) 2007 COMPLAINING OF NEW PAIN IN HER BACK. X-RAYS REVEALED BROKEN SCREWS AT THE S1 VERTEBRAL BODY. ON (B)(6) 2007, THE CONSTRUCT INCLUDING BROKEN SCREWS WAS REMOVED AND REPLACED WITH PROTEX SCREWS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.5MM REVERE PEDICLE SCREW 40MM PEDICLE SCREW HWC GLOBUS MEDICAL, INC. 124.474 JPG129TC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other