BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 6998472 · Received November 2, 2017

    Report

    Report Number
    3004774118-2017-00164
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 3, 2017
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    PMA / PMN Number
    K133944
    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 PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION WAS COMPLETED AS THE LOT NUMBER HAS BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE SCREW REMAINS IN THE PATIENT, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. X-RAY IMAGES APPEAR TO SHOW A SLIGHT HALOING AFFECT IMMEDIATELY ADJACENT TO THE BROKEN SCREW SHAFT. THIS EFFECT IS TYPICALLY ASSOCIATED WITH MOVEMENT OF THE SCREW POST-OPERATIVELY, WHICH MAY INDICATE THAT THE SCREW WAS SUBJECTED TO DYNAMIC LOADING LEADING TO FAILURE.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH BROKEN SCREW APPROXIMATELY 4 MONTHS POST-OP. THERE ARE NO PLANS TO REVISE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777166 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M, INC. CKED

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR