BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONT BLANC AND MONT BLANC MIS SPINAL SYSTEMS

    MDR report key: 9694268 · Received February 11, 2020

    Report

    Report Number
    3010758686-2020-00002
    Event Type
    Injury
    Date Received
    February 11, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 22, 2020
    Manufacturer
    SPINEWAY
    Product Code
    NKB
    PMA / PMN Number
    K161387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS UNDERGONE A SPINE SURGERY ON L5-L4 LEVELS. AT 3 MONTHS-FOLLOW UP, A LOCKING SCREW WAS FOUND OUTSIDE THE SCREW HEAD ON RADIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158035 MONT BLANC AND MONT BLANC MIS SPINAL SYSTEMS LOCKING SCREW NKB SPINEWAY MIS1LS 5181904S

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention