BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOPS SYSTEM

    MDR report key: 22490411 · Received July 13, 2025

    Report

    Report Number
    3012401682-2025-00006
    Event Type
    Injury
    Date Received
    July 13, 2025
    Date of Event
    June 12, 2025
    Report Date
    July 13, 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

    A REVIEW OF THE MANUFACTURING RECORDS OF THE INVOLVED LOT WAS PERFORMED AND INDICATED THAT THE INVOLVED LOT WAS MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS WITHOUT DEVIATIONS. THE EXPLANT WAS NOT YET OBTAINED FOR INVESTIGATION. THE RATE OF REVISIONS FOR THE TOPS SYSTEM IS LOWER THAN THE REPORTED RATES IN THE LITERATURE FOR SIMILAR SYSTEMS. IN THIS CASE NO DEVICE FAILURE WAS INDICATED AND THE REASON FOR THE REVISION WAS DUE TO THE LOOSENED SET SCREWS AND THE CAUSE MAY BE MULTIFACTORIAL, INCLUDING IMPROPER FINAL TIGHTENING DURING THE ORIGINAL PROCEDURE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE COMPANY WAS INFORMED OF A REVISION PROCEDURE FOR THE TOPS SYSTEM IN THE US. THE PATIENT WAS ORIGINALLY TREATED AT L4-L5 WITH A TOPS DEVICE ON (B)(6) 2022, AS PART OF THE US IDE CLINICAL STUDY, DUE TO GRADE I SPONDYLOLISTHESIS WITH SEVERE STENOSIS AT L4-5. DURING THE POSTOPERATIVE PERIOD, A RESOLUTION OF LEG PAIN AND IMPROVEMENT IN DISABILITY WERE EVIDENT, HOWEVER, THE PATIENT'S BACK PAIN NEVER FULLY RESOLVED. AFTER 24 MONTHS THE PATIENT'S LEG PAIN RETURNED AND X-RAYS SHOWED THAT THE L5 SET SCREW HAD DISENGAGED. ON (B)(6) 2025 THE SURGEON REMOVED THE ORIGINAL TOPS IMPLANT AND REPLACED WITH A NEW TOPS IMPLANT. THE SURGEON NOTED THAT THE RIGHT L5 SET SCREW WAS DISENGAGED FROM THE TULIP AND THE LEFT L5 SET SCREW WAS LOOSE. BOTH L4 SET SCREWS WERE LOCKED IN PLACE. ALL 4 PEDICLE SCREWS WERE SECURED INSIDE THE BONE WITH NO EVIDENCE OF LOOSENING. THERE WERE NO SIGNS OF INFECTION, IMPLANT DEBRIS, OR ABNORMAL BONE REACTION. MINIMAL TISSUE SCARRING AND GRANULATION TISSUE WAS NOTED AS WELL AS NEW BURSAL TISSUE AND SIGNS OF TISSUE DISCOLORATION. A NEW TOPS IMPLANT WAS INSERTED INTO THE EXISTING PEDICLE SCREWS; SET SCREWS WERE TIGHTENED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740927 TOPS SYSTEM MOTION-PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD 85858 RTP0528US

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention