BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPS SYSTEM

    MDR report key: 22726210 · Received August 6, 2025

    Report

    Report Number
    3012401682-2025-00009
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 7, 2025
    Report Date
    August 6, 2025
    Manufacturer
    PREMIA SPINE LTD.
    Product Code
    QWK
    PMA / PMN Number
    P220002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FAILURE WAS INDICATED IN THE ORIGINAL PROCEDURE OR IN THE EXPLANTS AT THE TIME OF REVISION. EXPLANTS WERE NOT RETURNED FOR INVESTIGATION AND NO ADDITIONAL INFORMATION ABOUT THE REVISION IS AVAILABLE AT THIS TIME. THE PRODUCT LOT COULD NOT BE OBTAINED; THEREFORE, DHR REVIEW COULD NOT BE PERFORMED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. BASED ON THE AVAILABLE INFORMATION THE REASON FOR THE REVISION SURGERY AND WHETHER IT IS RELATED TO THE TOPS SYSTEM COULD NOT BE DETERMINED. THE RATE OF REVISIONS FOR THE TOPS SYSTEM IS LOWER THAN THE REPORTED RATES IN THE LITERATURE FOR SIMILAR SYSTEMS. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE COMPANY WAS INFORMED ABOUT A REVISION CASE OF THE TOPS SYSTEM IN THE US. NO INFORMATION WAS PROVIDED REGARDING THE ORIGINAL PROCEDURE. IN THE REVISION SURGERY, THE TOPS MOTION IMPLANT AND PEDICLE SCREWS WERE REMOVED. NO OTHER DETAILS WERE PROVIDED AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364856 TOPS SYSTEM MOTION-PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention