BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIN PEAKS

    MDR report key: 12038991 · Received June 22, 2021

    Report

    Report Number
    3010758686-2021-00001
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SPINEWAY SA
    Product Code
    MAX
    UDI-DI
    03663422605375
    PMA / PMN Number
    K152355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    PROBLEMS UPON REMOVAL OF THE IMPACTOR, THIS TURNS AND BLOCKS, NOT ALLOWING EASY REMOVAL. IF THE MALFUNCTION WERE TO RECUR, IT IS REASONABLE TO CONSIDER THAT THE DEVICE WOULD BE LIKELY TO CONTRIBUTE TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943268 TWIN PEAKS IMPACTOR, TLIF CAGE MAX SPINEWAY SA 395IT1 214495 03663422605375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention