BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPS SYSTEM

    MDR report key: 20146988 · Received September 5, 2024

    Report

    Report Number
    3012401682-2024-00007
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 7, 2024
    Report Date
    September 5, 2024
    Manufacturer
    PREMIA SPINE LTD.
    Product Code
    QWK
    PMA / PMN Number
    P220002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE TWO SCREWDRIVERS UNDER A MICROSCOPE REVEALED A VERY SMALL BURR ON THE TIP. THIS IS THE FIRST TIME SUCH AN OCCURRENCE HAS BEEN REPORTED AND THE INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    COMPANY REPRESENTATIVE IN THE US REPORTED THAT THE TIP OF THE CANNULATED SCREWDRIVER DID NOT FIT INSIDE A PEDICLE SCREW. ANOTHER SCREWDRIVER WAS USED WITHOUT A PROBLEM WITH NO CHANGE IN THE CLINICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865108 TOPS SYSTEM MOTION-PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD. CANNULATED SCREWDRIVER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown