BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM

    MDR report key: 3890754 · Received June 12, 2014

    Report

    Report Number
    2184052-2014-00098
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREWS LOOSENED POST-OPERATIVELY. INDEX SURGERY TREATED L2-L5. REVISION SURGERY WAS PERFORMED. NO ADD'L INFO WAS AVAILABLE AT THE TIME OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348547 SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM SEQUOIA TI POLY SCREW ASSY 6.5MM X 45MM NKB ZIMMER SPINE 3306-6545 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention