BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPS SYSTEM

    MDR report key: 23486405 · Received November 6, 2025

    Report

    Report Number
    3012401682-2025-00013
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 6, 2025
    Report Date
    January 20, 2026
    Manufacturer
    PREMIA SPINE LTD.
    Product Code
    QWK
    UDI-DI
    07290014064010
    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

    THE EXPLANT WAS RETURNED AND A VISUAL ASSESSMENT IDENTIFIED SIGNS OF WEAR. EXAMINATION OF THE BOTTOM PLATE ARMS AND SET SCREWS INDICATED THAT THE SET SCREWS WERE NOT FULLY TIGHTENED, WHICH LIKELY RESULTED IN SLIPPAGE OF THE BOTTOM PLATE ARMS IN THE PEDICLE SCREWS AND SUBSEQUENT IMPLANT MISALIGNMENT. BASED ON THE AVAILABLE INFORMATION, IT WAS CONCLUDED THAT THE SUBSEQUENT SURGERY WAS MOST LIKELY RELATED TO THE SURGICAL TECHNIQUE EMPLOYED DURING THE ORIGINAL PROCEDURE RATHER THAN TO THE TOPS SYSTEM. REVISIONS, ASSOCIATED WITH SIGNS OF WEAR, HAVE BEEN PREVIOUSLY REPORTED IN A SMALL NUMBER OF CASES WHERE THE IMPLANT WAS REVISED, WITHOUT ANY SEQUELAE. THE CAUSE FOR THE REVISION SURGERY IN SUCH CASES MAY BE MULTIFACTORIAL, INCLUDING PATIENT AND PROCEDURE RELATED FACTORS. THE RATE OF REVISIONS FOR THE TOPS SYSTEM IS LOWER THAN THE REPORTED RATES IN THE LITERATURE FOR SIMILAR SYSTEMS.

    Additional Manufacturer Narrative · 0

    EXPLANT IS STILL IN TRANSIT AND NO ADDITIONAL INFORMATION ABOUT THE REVISION IS AVAILABLE AT THIS TIME; THEREFORE, 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 INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE COMPANY RECEIVED AN EXPLANT FROM A CLINIC IN THE US. NO INFORMATION WAS PROVIDED REGARDING THE REASON FOR DEVICE REMOVAL. NO OTHER DETAILS WERE PROVIDED. THE EXPLANT ARRIVED FOR INVESTIGATION AND WAS EXAMINED.

    Description of Event or Problem · 0

    THE COMPANY RECEIVED AN EXPLANT FROM A CLINIC IN THE US. NO INFORMATION WAS PROVIDED REGARDING THE REASON FOR DEVICE REMOVAL. NO OTHER DETAILS WERE PROVIDED AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2101 TOPS SYSTEM MOTION-PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD. 85858 RTU0791 07290014064010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention