BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE TLIF SPACER, SMALL, 12MM

    MDR report key: 1400210 · Received May 29, 2009

    Report

    Report Number
    3004142400-2009-00006
    Event Type
    Injury
    Date Received
    May 29, 2009
    Date of Event
    April 9, 2009
    Report Date
    April 30, 2009
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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. ADDITIONALLY, THE PRODUCT WAS RETURNED, EVALUATED AND MET REQUIRED SPECIFICATIONS. BASED ON RECORD REVIEW, PRODUCT EVALUATION, AND ALL AVAILABLE INFORMATION, IT IS DETERMINED THE SIGNATURE TLIF SPACER, SMALL, 12MM 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. CONCLUSIONS: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED - CAUSE OF EVENT UNKNOWN.

    Description of Event or Problem · 1

    GLOBUS MEDICAL INC. RECEIVED NOTIFICATION FROM A MEDICAL FACILITY, VIA A 3500A MEDWATCH FORM, THAT A GLOBUS MANUFACTURED SPACER HAD DISLODGED AFTER IMPLANTATION. IN 2009, THE PATIENT UNDERWENT A SPINAL LUMBER FUSION PROCEDURE USING A GLOBUS TLIF SPACER IMPLANT. A CT SCAN WAS PERFORMED APPROXIMATELY 4 WEEKS POST-OP AND REVEALED A DISLODGEMENT OF THE INTERBODY FUSION SPACER. APPROX TWO MONTHS LATER, THE PATIENT UNDERWENT SURGERY FOR THE REMOVAL OF THE SPACER. ANOTHER INTERBODY FUSION PROCEDURE WAS ACCOMPLISHED WITH THE USE OF BMP, MASTERGRAFT, AND ALLOGRAFT. THE PATIENT RECOVERED WELL POST-OPERATIVELY AND TWO DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. GLOBUS MEDICAL INC. WAS NOTIFIED OF THE COMPLAINT ON 04/30/2009 BY 3500A MEDWATCH FORM, FROM A MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE TLIF SPACER, SMALL, 12MM SIGNATURE TLIF SPACER KWQ GLOBUS MEDICAL, INC. 368.212 EAJ1717JA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention