BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA AND PATHFINDER NXT CLOSURE TOP

    MDR report key: 3971156 · Received July 8, 2014

    Report

    Report Number
    2184052-2014-00114
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE CLOSURE TOP BACK PUT POST-OPERATIVELY. LEVELS ORIGINALLY TREATED WERE L3-S1 WITH SEQUOIA INSTRUMENTATION. POST-OPERATIVE X-RAY SHOWED A SET SCREW AT S1 HAD BACK PUT. ADDITIONALLY THE PATIENT WAS NOT FUSED. THE PATIENT WAS BELIEVED TO BE COMPLIANT WITH ALL POST-OP INSTRUCTIONS. ALL SEQUOIA INSTRUMENTATION WAS REMOVED AND REPLACED WITH A COMPETITOR SYSTEM. THE PATIENT CURRENT CONDITION IS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398408 SEQUOIA AND PATHFINDER NXT CLOSURE TOP SEQUOIA AND PATHFINDER NXT CLOSUE TOP NKB ZIMMER SPINE, INC. 3301-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention