BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLIMT EXPANDABLE LIF CAGE

    MDR report key: 23325727 · Received October 17, 2025

    Report

    Report Number
    3009051471-2025-00022
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO INFORMATION OF THE DISC PREP PROVIDED. A NON-SYSTEM TORQUE-LIMITING HANDLE WAS USED, APPLYING TORQUE GREATER THAN THE SPECIFIED 2 NM. THE EXCESSIVE TORQUE, COMBINED WITH PARTIAL DEPTH ENGAGEMENT OF THE DRIVERS, CAUSED THE TIPS TO WARP AND SHEAR OFF INSIDE THE SET SCREWS. THE FRACTURED DRIVER TIPS ARE ENCAPSULATED WITHIN THE EXPANSION SCREWHEAD, POSING NO RISK OF HARM OR TISSUE CONTACT. THE IMPLANT AND INSERTER THEMSELVES FUNCTIONED AS DESIGNED, AND THE EVENT IS THE RESULT OF MISUSE. NOTE: THIS REPORT IS RELATED TO REPORT 3009051471-2025-00021 (INCIDENT INVOLVED TWO DEVICES).

    Description of Event or Problem · 0

    IN A TLIF PROCEDURE, A NON-SYSTEM TORQUE LIMITING HANDLE WAS USED WITH HIGHER TORQUE THAN THE RECOMMENDED 2 NM. THERE IS A 2 NM HANDLE PROVIDED IN THE SYSTEM SET, BUT THE USER DECIDED TO USE A DIFFERENT HANDLE WITH A HIGHER TORQUE LIMIT. THE IMPLANT/INSERTER FUNCTIONED AS DESIGNED. USING A HIGHER TORQUE FOR THE EXPANSION CAUSED THE TIP OF THE DRIVER TO WARP. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO THE SURGERY. WHEN THE PARTS WERE RETURNED IT WAS NOTICED THAT THE TIPS HAD SHEARED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319917 KLIMT EXPANDABLE LIF CAGE EXPANSION DRIVER MAX CTL MEDICAL CORPORATION 367.7508 FG8AA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown