BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUKON OCT SPINAL SYSTEM

    MDR report key: 7633271 · Received June 25, 2018

    Report

    Report Number
    3004774118-2018-00086
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 29, 2018
    Report Date
    May 30, 2018
    Manufacturer
    K2M INC.
    Product Code
    KWP
    PMA / PMN Number
    K171444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION BUT EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF EVALUATION OF THE SUBJECT PART, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT DURING A SURGERY A SCREW BROKE DURING INSERTION/IMPACTION. THE SHAFT OF THE SCREW REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478374 YUKON OCT SPINAL SYSTEM SPINAL FIXATION SYSTEM KWP K2M INC. GGWK

    Patients

    Seq Age Sex Outcome Treatment
    1