BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 4356181 · Received December 23, 2014

    Report

    Report Number
    1030489-2014-04837
    Event Type
    Injury
    Date Received
    December 23, 2014
    Date of Event
    December 3, 2014
    Report Date
    December 5, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 # 7750510, 510K # K062879 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 SPINAL FIXATION SURGERY AT OCCIPITAL¿C6. APPROXIMATELY ONE MONTH POST-OP IT WAS FOUND THAT ALL SIX OF THE SCREWS HAD BACKED OUT OF THE OC PLATE. THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 MONTHS POST-OP. THE SURGEON STATED THAT THE PATIENT'S RHEUMATOID ARTHRITIS MIGHT HAVE CONTRIBUTED TO THE INCIDENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846974 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0306321W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention