BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 4903426 · Received July 9, 2015

    Report

    Report Number
    1030489-2015-01427
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 10, 2015
    Report Date
    November 20, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    K121191
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES RECEIVED .THEREFORE THE CAUSE OF EVENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THIS PRODUCT WAS DONE AND NO FAULT WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY AND THE SURGEON ADDED SCREWS AT T1 <(>&<)> T2 TO THE EXISTING C3-C6 CONSTRUCT. THE SURGEON THEN WENT ON TO REMOVE THE C6 SCREW ON THE LEFT SIDE TO ACCOMMODATE AN AXIAL DOMINO CONNECTOR. AT DAY 3,POST-OP, X-RAYS REVEALED THE AXIAL DOMINO HAD "POPPED OFF" ACCORDING TO THE SURGEON WHO CALLED THE PATIENT BACK TWO DAYS LATER TO REMOVE THE AXIAL DOMINO AND REVISE. ON THE RIGHT THE SURGEON USED A SIDE TO SIDE DOMINO CONNECTOR, WHICH REMAINS INTACT. THE INSTRUMENT DID NOT BREAK. THERE WERE PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445754 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0125942W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention