BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS MEDICAL CO LTD

    MDR report key: 25097157 · Received May 6, 2026

    Report

    Report Number
    3005596514-2026-00002
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 5, 2026
    Manufacturer
    GS MEDICAL CO LTD
    Product Code
    KWQ
    PMA / PMN Number
    K190170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    DURING A POST-OPERATIVE FOLLOW-UP AFTER THE INITIAL SURGERY, IT WAS DETERMINED THAT A SECOND SURGICAL INTERVENTION WAS REQUIRED, WHICH LED TO A REVISION PROCEDURE. DURING THE REVISION SURGERY, ONE CAM AND ONE SCREW WERE FOUND TO HAVE DISENGAGED DUE TO THE LOCKING CAM BECOMING DISLODGED FROM THE PLATE AND RESULTED IN THE IMPINGEMENT OF ESOPHAGUS. THE PATIENT TOLERATED THE PROCEDURE WELL AND IS CURRENTLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169636 GS MEDICAL CO LTD CASSIOPEIA CERVICAL PLATE SYSTEM KWQ GS MEDICAL CO LTD 200617010, 200228034

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention