BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3198800 · Received July 1, 2013

    Report

    Report Number
    1030489-2013-02826
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 2, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7750506, 510K # K062879 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL PROCEDURE AT O-T2. IT WAS REPORTED THAT APPROXIMATELY Y 4 MONTHS POST-OP THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE OC SCREW BACKING OUT. THE SCREW WAS REMOVED AND THE DURA MATER WAS SUTURED DUE TO BEING DAMAGED. THE PLATE WAS ALSO REMOVED. AN OC PLATE WAS IMPLANTED ALONG WITH 8 SCREWS AND A ROD WHICH WAS CONNECTED TO THE PRIMARY CONSTRUCT WITH A DOMINO CONNECTOR. AUTO GRAFT WAS ALSO PERFORMED ALONG WITH CABLES BEING ADDED TO THE CONSTRUCT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297774 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0199717W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention