BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM X 14MM RIGID SCREW, SELF-DRILLING

    MDR report key: 1400207 · Received May 21, 2009

    Report

    Report Number
    3004142400-2009-00004
    Event Type
    Injury
    Date Received
    May 21, 2009
    Date of Event
    April 22, 2009
    Report Date
    April 22, 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. BASED ON A RECORD REVIEW AND ALL AVAILABLE INFORMATION, IT IS DETERMINED THE 4.0MM X 14MM RIGID SCREW, SELF-DRILLING DESIGN CONFORMS TO ALL APPLICABLE STANDARDS AND THERE WAS NO DEVIATION IN THE MANUFACTURE PROCESS. THERE IS NO INDICATION THAT THE ISSUE 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 SPINAL SURGERY AND THE SURGEON IMPLANTED A 4.0MM X 14MM RIGID SCREW, SELF-DRILLING (110.014). ON A SUBSEQUENT X-RAY, THE SCREW WAS FOUND TO HAVE BACKED OUT AND THE PATIENT RECEIVED REVISION SURGERY THREE MONTHS LATER. THE SURGEON REMOVED THE BACKED OUT SCREW AND THE SET SCREW, AND REPLACED IT WITH A 4.5MM X 16MM STANDARD SCREW, SELF-DRILLING. 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 4.0MM X 14MM RIGID SCREW, SELF-DRILLING ASSURE RIGID SCREW KWQ GLOBUS MEDICAL, INC. 110.014 BGJ226UE

    Patients

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