BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3001763 · Received March 13, 2013

    Report

    Report Number
    1030489-2013-00734
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 12, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K083071
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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 OCCIPITOCERVICAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR BROKEN RODS AND LATERAL MASS CREWS PULLING OUT AT C2. THE RODS WERE REMOVED AND REPLACED AS WELL AS THE SCREWS BEING REMOVED AND REPLACED. THE PATIENT WAS PLACED IN A HALO. PAIN AND NUMBING OF THE HANDS WENT AWAY. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105250 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention