BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 4215178 · Received October 30, 2014

    Report

    Report Number
    1030489-2014-04177
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 3, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    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 # 7750087, 510K # K070742 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 FUSION AT OCCIPITAL ¿ T2. APPROXIMATELY 10 MONTHS POST-OP THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE RODS FRACTURING BILATERALLY. THE RODS FRACTURED IN THE OCCIPITAL TO CERVICAL REGION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695314 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention