BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPS SYSTEM

    MDR report key: 23427252 · Received October 30, 2025

    Report

    Report Number
    3012401682-2025-00012
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    October 1, 2025
    Report Date
    October 30, 2025
    Manufacturer
    PREMIA SPINE LTD.
    Product Code
    QWK
    UDI-DI
    07290115932638
    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

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY IN PROGRESS TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION, AS APPROPRIATE.

    Description of Event or Problem · 0

    UPON COMPLETION OF IMPLANTATION AND FINAL TIGHTENING OF THE TOPS SYSTEM, THE US SURGEON REMOVED THE TOPS INSERTER AND NOTICED A PIN THAT HAD BROKEN OFF THE INSERTER'S TIP. THE SURGEON REMOVED THE PIN AND CONTINUED TO FINAL SUTURING OF THE PATIENT WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342890 TOPS SYSTEM MOTION-PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD. 20231805 07290115932638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown