BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA SPINAL SYSTEM

    MDR report key: 7048073 · Received November 21, 2017

    Report

    Report Number
    3004774118-2017-00186
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    PMA / PMN Number
    K133944
    Adverse Event
    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 WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    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 COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE PRODUCT HAS NOT BEEN RETURNED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. NO RELATIONSHIP COULD BE CONFIRMED RELATING K2M HARDWARE TO THE EVENT.

    Description of Event or Problem · 1

    ON 10.26.2017 IT WAS REPORTED TO K2M, INC. THAT SCREWS WERE IMPLANTED THEN EXPLANTED AND THE SURGERY WAS ABORTED DUE TO NEURAL MONITORING ALERT . SURGERY WAS RESCHEDULED AND PERFORMED ON (B)(6) 2015.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT SCREWS WERE IMPLANTED THEN EXPLANTED AND THE SURGERY WAS ABORTED DUE TO NEURAL MONITORING ALERT . SURGERY WAS RESCHEDULED AND PERFORMED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830856 MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other| R