BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPS SYSTEM

    MDR report key: 23777273 · Received December 11, 2025

    Report

    Report Number
    3012401682-2025-00015
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 9, 2025
    Report Date
    December 11, 2025
    Manufacturer
    PREMIA SPINE LTD.
    Product Code
    QWK
    PMA / PMN Number
    K231844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANY HAS NOT BEEN ABLE TO OBTAIN INFORMATION REGARDING THE ORIGINAL PROCEDURE, PATIENT CONDITION, AND LOT NUMBER OF IMPLANT INVOLVED. A FEW ATTEMPTS HAVE BEEN MADE TO OBTAIN THIS INFORMATION. THE EXPLANT WAS NOT RETURNED, NEVERTHELESS, NO INDICATION OF FAILURE OR MALFUNCTION WAS REPORTED. A PEDICLE FRACTURE CAN OCCUR FOR SEVERAL REASONS DURING OR AFTER SPINAL SURGERY, SUCH AS THE USE OF INCOMPATIBLE SCREW DIMENSIONS OR TRAJECTORY, FAILED ATTEMPTS AT SCREW REPOSITIONING, AGGRESSIVE FACET RESECTION AT THE PEDICLE ENTRANCE, POOR BONE QUALITY (E.G., BRITTLE OR HARD AND THIN) OR TRAUMA. 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 DUE TO A FRACTURED PEDICLE BONE. NO INFORMATION WAS PROVIDED REGARDING THE ORIGINAL PROCEDURE. IN THE REVISION SURGERY THE PEDICLE SCREW WAS REMOVED AND REPLACED WITH A NEW ONE. ALL OTHER IMPLANTS REMAINED IN-SITU. NO OTHER DETAILS WERE PROVIDED, AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2775777 TOPS SYSTEM MOTION PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention