BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONT BLANC

    MDR report key: 8363016 · Received February 22, 2019

    Report

    Report Number
    3010758686-2019-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Report Date
    February 19, 2019
    Manufacturer
    SPINEWAY
    Product Code
    NKB
    PMA / PMN Number
    K161387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE NOT RETURNED TO MANUFACTURER FOR EVALUATION. WE CAN'T KNOW WHICH IMPLANTS ARE BROKEN. A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED AFTER THE RECEPTION OF THE COMPLAINT ON THE WHOLE DEVICES IMPLANTED ON THIS PATIENT ACCORDING TO THE PREVIOUS AND ADDITIONAL PATIENT INFORMATION, WE ARE NOT ABLE TO CONCLUDE ON THE CAUSE OF THE BREAKAGE OF THE SCREW. OUR MAIN ASSUMPTION LIES IN THE LACK OF BONE FUSION. AGAIN, ACCORDING TO THE PATIENT INFORMATION, THE CAUSE OF THE LACK OF BONE FUSION AFTER 9 MONTHS IS UNKNOWN. THE LACK OF BONE FUSION MOST LIKELY CONTRIBUTED TO THE EXCESSIVE DYNAMIC STRESSES ONTO THE CONSTRUCT.    THE MONT BLANC SPINAL SYSTEMS INSTRUCTIONS FOR USE SPECIFIES THAT THE IMPLANTS ARE NOT INDICATED FOR PERMANENT FIXATION. INDEED, THEY ARE INTENDED TO FACILITATE ARTHRODESIS OF THE SPINE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT 2 SCREWS BROKE APPROXIMATELY 9 MONTHS AFTER THE SURGERY OF(B)(6) 2017 AND THE PATIENT FEELS PAIN. THERE ARE NO PLANS TO REVISE THE SYSTEM AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157696 MONT BLANC THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB SPINEWAY MB1PS640 1160184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention