BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3801930 · Received May 9, 2014

    Report

    Report Number
    1030489-2014-02450
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    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)(6). (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 SPINAL SURGERY AT C4-6 TO TREAT A TRAUMA INJURY. AFTER THE PROCEDURE WAS COMPLETE IT WAS FOUND ON X-RAY THAT THERE MAY BE A SCREW MALPOSITIONED. CT ANGIOGRAPHY AND REVISION SURGERY WERE PERFORMED TO REPLACE A SCREW AT C4 LEFT AND REMOVE ANOTHER SCREW AT C4 RIGHT, WITH CONTINUED GENERAL ANESTHESIA FROM THE INITIAL SURGERY. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED C5 PALSY POST-OP. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281827 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RODS, SCREW