BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPS SYSTEM

    MDR report key: 22592398 · Received July 24, 2025

    Report

    Report Number
    3012401682-2025-00008
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 2, 2025
    Report Date
    October 1, 2025
    Manufacturer
    PREMIA SPINE LTD.
    Product Code
    QWK
    PMA / PMN Number
    P220002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS SENT TO HEADQUARTERS WHERE AN INVESTIGATION WAS INITIATED. IT WAS FOUND THAT THE ISSUE WAS THE RESULT OF REWORK PERFORMED ON A LIMITED NUMBER OF INSERTER LOTS. THE AFFECTED LOTS HAVE BEEN SEGREGATED AND ARE BEING RETURNED FOR FURTHER INVESTIGATION. THIS INVESTIGATION IS ONGOING AND A SUPPLEMENTAL MDR WILL BE SUBMITTED, AS NEEDED.

    Additional Manufacturer Narrative · 0

    A TOTAL OF THREE INSERTERS FROM THE SAME LOT WERE FOUND WITH MISSING PINS DURING INSTRUMENT REPROCESSING BY THE COMPANY. ONE INSERTER WAS RETURNED FROM A CLINICAL PROCEDURE; A POST-SURGERY CT SCAN VALIDATED THAT THE METAL PIN WAS NOT IN THE PATIENT. FOR THE OTHER TWO INSERTERS, THE BREAKAGE CLEARLY COULD NOT HAVE OCCURRED DURING A SURGICAL PROCEDURE. THE THREE INSTRUMENTS WERE PART OF A GROUP OF TOPS INSERTERS THAT WERE SUBJECTED TO REWORK. FURTHER INVESTIGATION, INCLUDING INVESTIGATION OF THE REWORK PROCESS AT THE SUBCONTRACTOR, HAS DETERMINED THAT THE REWORK WAS THE ROOT CAUSE. ALL AFFECTED UNITS HAVE BEEN IDENTIFIED, LOCATED, MARKED AS REJECTED AND SEGREGATED.

    Description of Event or Problem · 0

    DURING AN INSPECTION OF A TOPS INSERTER WHICH WAS RETURNED TO OUR LOGISTICS CENTER FROM A SURGICAL CASE, IT WAS FOUND THAT A PIN WAS MISSING FROM THIS INSTRUMENT.

    Description of Event or Problem · 0

    DURING AN INSPECTION OF A TOPS INSERTER WHICH WAS RETURNED TO OUR LOGISTICS CENTER FROM A SURGICAL CASE, IT WAS FOUND THAT A PIN WAS MISSING FROM THIS INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859664 TOPS SYSTEM MOTION-PRESERVING SPINAL IMPLANT QWK PREMIA SPINE LTD. RS20220546-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown