BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM X 16MM STANDARD SCREW, SELF-DRILLING

    MDR report key: 1400208 · Received May 22, 2009

    Report

    Report Number
    3004142400-2009-00005
    Event Type
    Injury
    Date Received
    May 22, 2009
    Date of Event
    April 23, 2009
    Report Date
    April 23, 2009
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    KWQ
    Adverse Event
    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. A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL RECORDS, MANUFACTURING 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 PRODUCT WAS RETURNED FOR EVALUATION AND MET ALL PERFORMANCE TESTS AND SPECIFICATIONS. BASED ON A RECORD REVIEW AND ALL AVAILABLE INFORMATION, IT IS DETERMINED THE 4.5MM X 16MM STANDARD SCREW, SELF-DRILLING DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS. THERE IS NO INDICATION THAT THE BACK OUT OF THE SCREW WAS A RESULT OF PRODUCT DEFECT OR MALFUNCTION.

    Description of Event or Problem · 1

    GLOBUS MEDICAL INC. RECEIVED NOTIFICATION FROM A REPRESENTATIVE, VIA A COMPANY REPRESENTATIVE, THAT A GLOBUS MANUFACTURED SCREW HAD BACKED OUT AFTER IMPLANTATION. IN 2009, A FEMALE PATIENT, UNDERWENT SURGERY AND HAD A GLOBUS MANUFACTURED 4.5MM X 16MM STANDARD SCREW, SELF-DRILLING (110.716) SCREW IMPLANTED. THE FOLLOWING DAY, A FOLLOW-UP FILM WAS TAKEN AND REVEALED THE SCREW HAD BACKED-OUT APPROXIMATELY 4MM. THE PATIENT UNDERWENT SUBSEQUENT SURGERY ON THE SAME DAY, AND THE SURGEON REMOVED THE SCREW BUT DID NOT REPLACE THE PLACE DUE TO THE POOR BONE QUALITY OF THE PATIENT. GLOBUS MEDICAL INC. WAS NOTIFIED OF THE COMPLAINT ON THE SAME DAY, BY A GLOBUS MEDICAL, INC. REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM X 16MM STANDARD SCREW, SELF-DRILLING ASSURE STANDARD SCREW KWQ GLOBUS MEDICAL, INC. 110.716 BSG178AC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention ASSURE PLATE