BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLIMT EXPANDABLE LIF CAGE

    MDR report key: 23325720 · Received October 17, 2025

    Report

    Report Number
    3009051471-2025-00019
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Report Date
    October 17, 2025
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    MAX
    PMA / PMN Number
    K233947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PATIENT INJURY OR ADVERSE OUTCOME WAS REPORTED. NO SURGICAL REPORT WAS PROVIDED DETAILING PATIENT ANATOMY OR TECHNIQUE USED DURING IMPLANTATION. EXAMINATION OF THE RETURNED INSTRUMENTS SHOWED TWISTED DEFORMATION CONSISTENT WITH THE APPLICATION OF TORQUE BEYOND THE MATERIAL'S ALLOWABLE STRENGTH. THE REPRESENTATIVE CONFIRMED THAT THE DRIVERS WERE NOT FULLY SEATED INTO THE IMPLANT PRIOR TO EXPANSION, AND ONE DRIVER SHEARED AT THE DISTAL END. THE INCOMPLETE ENGAGEMENT, COMBINED WITH EXCESSIVE TORQUE APPLICATION, GENERATED STRESSES EXCEEDING THE DESIGN LIMITS OF THE INSTRUMENT. THE EVENT IS ATTRIBUTED TO USER MISUSE AND IMPROPER TECHNIQUE.

    Description of Event or Problem · 0

    THE SUBJECT DEVICE IS AN EXPANSION DRIVER FOR A TLIF EXPANDABLE CAGE. THE DEVICE WAS RETURNED TO THE MANUFACTURER WITH NO PRIOR NOTICE FROM THE USER. UPON EVALUATION OF THE PART IT WAS NOTICED THAT THE DRIVER TIP WAS BROKEN. THE MANUFACTURER CONTACTED THE USER AND WAS TOLD THAT THE DRIVER STRIPPED DUE TO NOT BEING FULLY SEATED INSIDE THE CAGE WHEN EXPANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300616 KLIMT EXPANDABLE LIF CAGE EXPANSION DRIVER MAX CTL MEDICAL CORPORATION 367.7505 FA8BC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown