BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3181581 · Received June 21, 2013

    Report

    Report Number
    1030489-2013-02447
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    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 # 6958830, 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 LAMINOPLASTY (C3-C6), LAMINECTOMY AND FIXATION (C7-T1) WITH PEDICLE SCREWS. THE PATIENT¿S SYMPTOMS WERE RELIEVED POST-OP, BUT REOCCURRED TWO DAYS POST-OP. IMAGE DIAGNOSIS SUSPECTED THAT INSUFFICIENT DECOMPRESSION INTRODUCED RADICULOPATHY. MOREOVER, IT WAS CONFIRMED THAT SCREWS PLACED AT RIGHT C7 AND TH1 PERFORATED VERTEBRAE LATERALLY. THE PATIENT UNDERWENT A REVISION SURGERY 12 DAYS POST-OP FOR RE-DECOMPRESSION AND THE PERFORATED SCREWS WERE REMOVED AND REPLACED. THE SURGEON COMMENTED THAT THE NERVE ROOT WAS PULLED BECAUSE THE SPINAL NERVES WERE SUSPENDED AFTER DECOMPRESSION, AND THAT CAUSED RADICULOPATHY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282853 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1