BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA TI POLY SCREW ASSY 8.5MM X 45MM

    MDR report key: 3971159 · Received July 8, 2014

    Report

    Report Number
    2184052-2014-00105
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS: 2184052-2014-00106. IT WAS REPORTED THE PATIENT EXPERIENCED INFLAMMATION AT THE SCREW IMPLANT SITE POST-OPERATIVELY. L4-S1 WAS TREATED USING A SEQUOIA INSTRUMENTATION AND COMPETITOR PEEK INTERBODIES. APPROXIMATELY 14 MONTHS LATER THE PATIENT WAS FUSED AT L4-L5 AND L5-S1 BUT THERE WAS INFLAMMATION AT THE SACRAL SCREWS DUE TO THE LEVERAGE OF THE RODS. THE SURGEON DECIDED TO PERFORM A REMOVAL SURGERY. THERE WAS HOWEVER DIFFICULTY IN REMOVING THE SCREWS SO ONLY THE RODS AND CLOSURE TOPS WERE REMOVED AND THE SCREWS WERE LEFT IN THE PATIENT. THE INFLAMMATION WAS RESOLVED SINCE THE RODS AND SET SCREWS WERE REMOVED, THUS NO LONGER PULLING ON THE SACRAL SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398409 SEQUOIA TI POLY SCREW ASSY 8.5MM X 45MM SEQUOIA TI POLY SCREW ASSY 8.5MM X 45MM NKB ZIMMER SPINE, INC. 3306-8545 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention