BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3474154 · Received November 18, 2013

    Report

    Report Number
    1030489-2013-04558
    Event Type
    Injury
    Date Received
    November 18, 2013
    Date of Event
    October 6, 2013
    Report Date
    October 20, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 # 6958710, 510K # K081297 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 FUSION AT C5-6 TO TREAT A DISLOCATION FRACTURE. IT WAS REPORTED THAT SOMETIME POST-OP THE PEDICLE SCREW DEVIATED FROM THE PEDICLE AND THAT MAY HAVE CAUSED STENOSIS IN THE VERTEBRAL ARTERY. NO REVISION SURGERY IS PLANNED AS OF YET. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595396 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H11B6142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other