BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPS SYSTEM

    MDR report key: 19527104 · Received June 13, 2024

    Report

    Report Number
    3012401682-2024-00006
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 13, 2024
    Manufacturer
    PREMIA SPINE LTD.
    Product Code
    QWK
    PMA / PMN Number
    P220002
    Product Problem
    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. THE WELDING CONNECTION BETWEEN THE UPPER KNOB AND THE INNER SHAFT OF THE TOPS INSERTER BROKE. AN INVESTIGATION OF THE ISSUE DID NOT REVEAL A DESIGN OR MANUFACTURING PROBLEM. THE TOPS INSERTERS HAVE BEEN USED IN MORE THAN 2,000 PROCEDURES OVER A DECADE WITH NO OTHER REPORTS OF INSERTER SHAFT BREAKAGE. IT SHOULD BE NOTED THAT THE WELDING CONNECTION BETWEEN THE TWO PARTS OF THE INSERTER HAS REMAINED UNCHANGED DURING THIS PERIOD OF TIME. THIS HAS LED TO THE CONCLUSION THAT THE INVOLVED INSTRUMENT WHICH WAS SUBJECTED TO REPEATED CYCLES OF USE, MIGHT HAVE BEEN DAMAGED DURING REPROCESSING, OR EXPERIENCED EXCESSIVE USE OF FORCE DURING THE CLINICAL PROCEDURE. THE RISK ASSOCIATED WITH THIS INCIDENT IS LOW SINCE GENERAL TOOLS, WHICH ARE AVAILABLE IN THE OPERATING ROOM, CAN BE USED TO REMOVE THE TOPS IMPLANT FROM THE INSERTER AS REPORTED IN THIS CASE.

    Description of Event or Problem · 0

    THE COMPANY RECEIVED A REPORT THAT AN INSTRUMENT USED WITH THE TOPS SYSTEM BROKE DURING A PROCEDURE IN THE US. THE INSTRUMENT (TOPS INSERTER) WAS RETURNED FOR INVESTIGATION. VISUAL EXAMINATION OF THE INSERTER INDICATED THAT IT BROKE AT THE CONNECTION BETWEEN THE UPPER KNOB TO THE INNER SHAFT WHICH ARE CONNECTED BY WELDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184271 TOPS SYSTEM MOTION-PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD. RS20220546

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown