BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM REVERE PEDICLE SCREW 40MM

    MDR report key: 1058724 · Received June 6, 2008

    Report

    Report Number
    3004142400-2008-00005
    Event Type
    Injury
    Date Received
    June 6, 2008
    Date of Event
    May 8, 2008
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    MCV
    PMA / PMN Number
    K061202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE REPORT. ALTHOUGH THE SCREWS WERE NOT RETURNED FOR EVALUATION, A COMPREHENSIVE REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCTS WERE MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. AN EXPECTED REVISION SURGERY IS TENTATIVELY SCHEDULED FOR 2008, AS REPORTED BY THE HOSPITAL. THE REPORT STATES APPROX 3 MONTHS HAD ELAPSED FROM IMPLANTATION AND EVIDENCE OF A BREAKAGE. THERE ARE MANY PT FACTORS THAT CAN CONTRIBUTE TO A SCREW BREAKAGE DURING THIS TIME AND THE PACKAGE INSERT WARNS THAT "THE PT'S WEIGHT AND ACTIVITY HAVE AN EFFECT ON THE STRESSES OF THE IMPLANT" AND "PT'S ANATOMY SHOULD BE CONSIDERED WHEN SELECTING SCREW DIAMETER AND LENGTH." ADDITIONALLY, PUBLISHED STUDIES INDICATE THAT SCREWS UTILIZED IN THIS ANATOMICAL AREA HAVE FAILURE RATES AS HIGH AS 12.4%, "THE USE OF PEDICLE-SCREW INTERNAL FIXATION FOR THE OPERATIVE TREATMENT OF SPINAL DISORDERS," ROBERT W GAINES JR, JBJS AM 2000: 82:1458; "COMPLICATIONS OF PEDICLE SCREWS IN LUMBAR AND LUMBOSACRAL FUSIONS IN 105 CONSECUTIVE PRIMARY OPERATIONS," P.C. JUTTE, R.M. CASTELEIN, EUR SPINE J, 2002011:594-598. BASED ON RECORD REVIEW AND ALL AVAILABLE INFO, IT WAS DETERMINED THE REVERE SCREW DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS. THERE IS NO INDICATION THE BREAKAGE WAS A RESULT OF PRODUCT DEFECT, MALFUNCTION, OR POSES ANY INJURY WITH USE. ALL RECORDS PURPORT THE SCREW WAS OF THE HIGHEST QUALITY AND SAFETY.

    Description of Event or Problem · 1

    GLOBUS MEDICAL RECEIVED NOTIFICATION FROM A SALES REP, VIA A COMPANY PROCESSING/EVALUATION FORM, THAT TWO (2) GLOBUS MANUFACTURED SCREWS HAD BROKEN AFTER IMPLANTATION. IT WAS REPORTED A PT UNDERWENT SPINAL SURGERY AT L4-S1 IN 2008. THREE MONTHS POST-OP THE PT WAS DOING FINE, BUT HEARD "SQUEAKING" IN HIS BACK. AN MRI WAS PERFORMED AND REVEALED THAT TWO (2) SCREWS AT S1 HAD BROKEN IN THE SHAFT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM REVERE PEDICLE SCREW 40MM PEDICLE SCREW MCV GLOBUS MEDICAL, INC. 124.464 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention