BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA AND PATHFINDER NXT CLOSURE TOP

    MDR report key: 3908189 · Received June 5, 2014

    Report

    Report Number
    2184052-2014-00091
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2014-00090. IT WAS REPORTED THAT THE CLOSURE TOPS WERE FOUND TO BE LOOSE POST-OPERATIVELY. THREE DAYS POST-OPERATIVELY THE PATIENT PRESENTED WITH STRONG PAIN. ON THE SIXTH DAY POST-OPERATIVELY THE PATIENT UNDERWENT REVISION SURGERY. THE SURGEON IMPLANTED A SECOND TM-ARDIS CAGE AT THE SAME LEVEL. THE ROD ON THE RIGHT SIDE WAS REMOVED AND IT WAS THEN FOUND THE SET SCREWS WERE LOOSE AND REMOVED WITH ALMOST NO FORCE. THE TWO SET- SCREWS AS WELL AS THE TWO PEDICLE SCREWS WERE RE-IMPLANTED IN THE PATIENT AND A LONGER ROD WAS USED TO COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330232 SEQUOIA AND PATHFINDER NXT CLOSURE TOP SEQUOIA AND PATHFINDER NXT CLOSURE TOP NKB ZIMMER SPINE, INC. 3301-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention