BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPS SYSTEM

    MDR report key: 23413049 · Received October 29, 2025

    Report

    Report Number
    3012401682-2025-00011
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 29, 2025
    Manufacturer
    PREMIA SPINE LTD.
    Product Code
    QWK
    UDI-DI
    07290014064034
    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

    A REVIEW OF THE MANUFACTURING RECORDS OF THE INVOLVED LOT WAS PERFORMED AND INDICATED THAT IT WAS MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS WITHOUT DEVIATIONS. AT THE TIME OF THE REMOVAL, THE IMPLANTS APPEARED WELL PRESERVED, AND THERE WERE NO SPECIAL IMPLANT-RELATED OBSERVATIONS. THE EXPLANT WAS NOT RECEIVED AT THE TIME OF THIS REPORT. BASED ON THE INFORMATION AVAILABLE TO DATE, THE EVENT SEEMS TO BE RELATED TO DISCOGENIC DEGENERATION RATHER THAN TO THE TOPS SYSTEM. THE RATE OF REVISIONS FOR THE TOPS SYSTEM IS LOWER THAN THE REPORTED RATES IN THE LITERATURE FOR SIMILAR SYSTEMS. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE.

    Description of Event or Problem · 0

    THE COMPANY WAS INFORMED ABOUT A REVISION CASE OF THE TOPS SYSTEM IN THE US AFTER MORE THAN 5 YEARS. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2020. THE PATIENT WAS TREATED WITH TOPS AT L4-L5 AS PART OF THE US IDE CLINICAL STUDY. THE PATIENT COMPLAINED OF AN INCREASE IN BACK PAIN. BASED ON THE PATTERN OF PAIN, PATIENT EXAM AND IMAGING ANALYSIS, THE SURGEON SUSPECTED THAT THE MAJOR PAIN GENERATOR IS LIKELY DISC DEGENERATION AT THE LEVEL OF THE TOPS DEVICE. IN THE REVISION SURGERY, THE TOPS SYSTEM WAS REMOVED AND FUSION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2741565 TOPS SYSTEM MOTION-PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD. 82644 RTP0242US 07290014064034

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention