BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA AND PATHFINDER NXT CLOSURE TOP

    MDR report key: 3943540 · Received April 30, 2014

    Report

    Report Number
    2184052-2014-00078
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLOSURE TOP WAS FOUND TO BE LOOSE POST-OPERATIVELY. TWO WEEKS AFTER SURGERY WITH PATHFINDER NXT INSTRUMENTATION, A CT SCAN WAS PERFORMED. IT WAS NOTED THE ONE CLOSURE TOP WAS LOOSE FROM THE SCREW. THE CLOSURE TOP REMAINS IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258715 SEQUOIA AND PATHFINDER NXT CLOSURE TOP SEQUOIA AND PATHFINDER NXT CLOSURE TOP NKB ZIMMER SPINE 3301-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1