BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE TWO: SECURE-C ENDPLATE ASSEMBLY, 11X12

    MDR report key: 4092240 · Received August 20, 2014

    Report

    Report Number
    3004142400-2014-00040
    Event Type
    Injury
    Date Received
    August 20, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    GLOBUS MEDICAL, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED SECURE-C ENDPLATE ASSEMBLY WAS RECEIVED ON (B)(4) 2014. EVALUATION OF THE ENDPLATE BEARING SURFACES ELICITED NO MAJOR DAMAGES, FRACTURES, OR SIGNS OF ANY FAILURE. BONY DEPOSITS WERE OBSERVED ON THE BONY APPOSITION SITE OF BOTH ENDPLATES. A SCRATCH MARK WAS NOTICED ON THE ANTERIOR ASPECT OF THE BONY APPOSITION SURFACE OF THE INFERIOR ENDPLATE CONSISTENT WITH THE USE OF A SURGICAL TOOL. THE BEARING SURFACES OF BOTH THE SUPERIOR AND INFERIOR ENDPLATES HAD NO VISIBLE SIGNS OF DAMAGE. PLEASE BE ADVISED THE SECURE-C IMPLANT IS COMPRISED OF TWO PARTS, I.E. PART NUMBER 714.106S SECURE-C ENDPLATE ASSEMBLY, AND PART NUMBER 414.108S SECURE-C CORE. THESE TWO PARTS COMBINED MAKE UP THE SECURE C IMPLANT.

    Description of Event or Problem · 1

    PATIENT WAS EXPERIENCING ACUTE NECK PAIN APPROXIMATELY 2.5 WEEKS POST-OP. INITIAL SURGERY WAS (B)(6) 2014. REVISION SURGERY TOOK PLACE (B)(6) 2014 TO REMOVE SECURE C CORE, UPPER ENDPLATE, AND LOWER ENDPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500645 DEVICE TWO: SECURE-C ENDPLATE ASSEMBLY, 11X12 SECURE-C ENDPLATE ASSEMBLY KWP GLOBUS MEDICAL, INC. 714.106S GBP291AH

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention