BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 2428577 · Received January 26, 2012

    Report

    Report Number
    1030489-2012-00083
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Report Date
    December 27, 2011
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-UNION. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 6900240, 510K # K003780 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. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION SURGERY. THE IMPLANTS WERE DISCARDED. NO ADDITIONAL PATIENT INFO WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE FROM THE OCCIPITAL TO T4. SOMETIME POST-OP IT WAS FOUND THAT THE ROD WAS BROKEN JUST BELOW THE OCCIPITAL BONE. FUSION IS NOT COMPLETE. A REVISION SURGERY HAS BEEN SCHEDULED BUT HAS NOT TAKEN PLACE YET. NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA W07A5318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS