BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER CERVICAL PLATE SYSTEM

    MDR report key: 1583466 · Received January 19, 2010

    Report

    Report Number
    3005031160-2010-00001
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    December 18, 2009
    Report Date
    December 21, 2009
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K052292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: SPINAL SURGERY - THREE LEVEL C3-C7 FUSION. ACCORDING TO THE REPORTER: 6 MONTHS AFTER THE INITIAL SURGERY, BOTH C7 SCREWS BROKE AND BACKED OUT. THE VERTEBRAE HAS FUSED AND BOTH C7 SCREWS WERE REMOVED IN 2009. ABOUT 3MM OF EACH SCREW WERE LEFT IN THE VERTEBRAL BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER CERVICAL PLATE SYSTEM CERVICAL PLATE SPINAL SYSTEM KWQ X-SPINE SYSTEMS, INC. N60000137 77395

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention