BEUDAMED
    FDA Adverse Event Other Summary report: N

    7.5MM REVERE PEDICLE SCREW 40MM

    MDR report key: 876248 · Received July 6, 2007

    Report

    Report Number
    3004142400-2007-00004
    Event Type
    Other
    Date Received
    July 6, 2007
    Date of Event
    May 17, 2007
    Report Date
    July 5, 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

    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. THESE SCREWS WERE IMPLANTED IN THE SACRUM DURING A LUMBAR FUSION. NO INTERBODY DEVICES WERE IMPLANTED DURING THE PROCEDURE. POST OPERATIVELY, THE PATIENT WAS INVOLVED IN A MINOR ACCIDENT IN WHICH SHE TRIPPED DURING A PHYSICAL REHABILITATION ACTIVITY. IN HER REPORT, SHE NOTED THAT SHE STUMBLED DURING WALKING. WHEN SHE FELL, HER KNEE SKINNED THE GROUND. AFTER THE INCIDENT, THE PT COMPLAINED OF A STRANGE FEELING IN HER BUTTOCK AREA. DURING A POST OP VISIT TO THE SURGEON, AN X-RAY REVEALED THAT THE 2 SACRAL SCREWS HAD BROKEN. IN THE PERIOD OF TIME IMMEDIATELY AFTER SURGERY, THE IMPLANTS ARE REQUIRED TO WITHSTAND MOST OF THE LOAD UNTIL A FUSION OCCURS. IT IS WELL DOCUMENTED THAT IMPLANTS CAN AND DO FAIL, WHEN A FUSION IS NOT PRESENT. 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%. A TRAUMATIC EVENT DURING THIS PERIOD MAY LEAD TO A FAILURE AS HAPPENED IN THIS CASE. THIS PATIENT MAY ALSO 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. 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 MEDICAL CENTER 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 124.474. A 7.5MM REVERE PEDICLE SCREW 40MM. "GLOBUS GROUP ENGINEERING MGR REC'D A CALL TODAY FROM REP THAT DR REPORTED, THAT HE WAS A PT WHO CAME IN FOR A 6 WEEK POST-OP VISIT. THE PT WAS A FEMALE WHO HAD UNDERGONE A L4-S1 POSTERIOR -LATERAL FUSION. UPON EXAMINATION OF THE X-RAYS, TWO SCREWS IN THE SACRUM WERE BROKEN. THE PT WAS ASYMPTOMATIC. PATIENT REPORTED THAT SHE HAS FALLEN AND EXPERIENCED AN ABNORMAL FEELING IN HER BUTTOCK AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7.5MM REVERE PEDICLE SCREW 40MM PEDICLE SCREW MCV GLOBUS MEDICAL, INC. 124.474 JPG111EC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other