BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.5MM REVERE PEDICLE SCREW 40MM

    MDR report key: 1065866 · Received June 18, 2008

    Report

    Report Number
    3004142400-2008-00007
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    February 6, 2008
    Report Date
    June 17, 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 COMPLAINT AND PRODUCT. A REVIEW WAS CONDUCTED ON ALL APPLICABLE MATERIAL RECORDS, MFG RECORDS, STORAGE RECORDS, AND DISTRIBUTION RECORDS. ALL RECORDS REVEALED THE PRODUCT WAS MANUFACTURED WITHIN SPECIFICATIONS, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL FEDERAL, STATE AND OPERATING PROCEDURES. THE SCREW WAS RETURNED FOR TEST AND EVAL. THE FIRST OBSERVATION IS THAT THE SCREW APPEARS TO BE BROKEN JUST BELOW THE SPHERICAL HEAD. ALSO, THE SCREW APPEARS TO HAVE BEEN DAMAGED UPON REMOVAL. 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 A RECORD REVIEW, TESTING, OBSERVATION, AND ALL AVAILABLE INFO, IT IS DETERMINED THE REVERE PEDICLE SCREW DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MFR PROCESS. THERE IS NO INDICATION THAT 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 DISTRIBUTOR, VIA A COMPANY PROCESSING/EVAL FORM, THAT A GLOBUS MANUFACTURED SCREW HAD BROKEN AFTER IMPLANTATION. THE ONLY INFO REPORTED IS THAT THE SCREW SNAPPED AT THE "NECK" OF THE SCREW IMPLANT POST-OPERATIVELY. THE IMPLANT WAS REMOVED IN 2008. GLOBUS MEDICAL WAS NOTIFIED OF THE COMPLAINT AND RECEIVED THE BROKEN SCREW ON 5/19/2008.

    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 GMG254CE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention