BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUOIA IMPLANT GENERIC

    MDR report key: 4172397 · Received October 9, 2014

    Report

    Report Number
    2184052-2014-00182
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD RADIOLUCENCY AND LOCAL PAIN AROUND L5. THE PATIENT THEN UNDERWENT A REVISION SURGERY. THE PATIENT ALSO HAD EXCELLENT FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636809 SEQUOIA IMPLANT GENERIC SEQUOIA IMPLANT GENERIC NKB ZIMMER SPINE 3300 SEQUOIA IMPLANT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention