BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLIMT EXPANDABLE LIF CAGE

    MDR report key: 23325755 · Received October 17, 2025

    Report

    Report Number
    3009051471-2025-00020
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    September 23, 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 PATIENT INJURY OR SURGICAL DELAY WAS REPORTED. DURING SURGERY, THE TORQUE-LIMITING HANDLE SUCCESSFULLY REACHED ITS DESIGNED EXPANSION CAPACITY. THE SURGEON, HOWEVER, CONTINUED TO ROTATE THE HANDLE MULTIPLE TIMES AFTER THE TORQUE LIMITS. THIS REPETITION EXCEEDED THE MECHANICAL DESIGN THRESHOLD OF THE DRIVER TIP, RESULTING IN TORSIONAL OVERLOAD AND HEARING OF THE TIP. THE OBSERVED FAILURE IS CONSISTENT WITH MISUSE AND OVER-APPLICATION OF TORQUE BEYOND THE VALIDATED DESIGN PARAMETERS.

    Description of Event or Problem · 0

    DURING A TLIF PROCEDURE: SURGEON COMPLETED ALL STEPS OF THE DISCECTOMY AND FIRST CAGE INSERTION (NON-CTL) AS NORMAL. WHEN HE WAS EXPANDING THE CAGE THE FIRST TIME, THE INSERTER DID NOT CATCH THE CONNECTION OF THE IMPLANT. ONCE WE RESOLVED THIS ISSUE, HE WAS ABLE TO EXPAND THE IMPLANT. UPON REACHING THE TORQUE LIMIT, THE REP INFORMED THE SURGEON THAT HE WAS FULLY EXPANDED TO THE CAPACITY OF THE TORQUE DRIVER. HE CONTINUED TO TURN THE TORQUE HANDLE AND IT DID SOUND LIKE THERE WAS SOME SLIGHT ADDITIONAL EXPANSION OCCURING WITH EACH TURN OF THE HANDLE BUT THE HANDLE TORQUED OUT SOON AFTER THAT. HE REPEATED THIS ABOUT 10-15 TIMES. THEN THE HANDLE TORQUED OUT AND STARTED SPINNING FREELY, INDICATING THE TIP HAD BEEN SHEARED OFF. HE PACKED THE SPACE WITH BONE GRAFT AFTER DETERMINING THE PIECE OF THE INSERTER COULD NOT BE REMOVED FROM THE INNER CONNECTION OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298664 KLIMT EXPANDABLE LIF CAGE EXPANSION DRIVER MAX CTL MEDICAL CORPORATION 367.7508 FG8AA*

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown