BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO PLOL CAGE SYSTEM

    MDR report key: 22413830 · Received July 7, 2025

    Report

    Report Number
    3009051471-2025-00014
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 9, 2025
    Report Date
    July 7, 2025
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    LXH
    PMA / PMN Number
    K121892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSERTER TIP BREAKAGE WAS DUE TO EXCESSIVE STRESS FROM SURGICAL TECHNIQUE DURING CONTRALATERAL INSERTION. THE INSERTER TIP IS NOT MEANT TO WITHSTAND FORCES THAT ARE PRESENT WHEN THE CAGE IS ROTATED 90 DEGREES IN THE DISC SPACE. THIS TECHNIQUE IS NOT ADVISED BY CTL AMEDICA, AND IS THE CAUSE OF THIS INSTRUMENT FAILURE.

    Description of Event or Problem · 0

    DURING A PLIF SPINAL SURGERY, TWO DIFFERENT CAGE INSERTER TIPS HAD FRACTURED DOWN THE MIDDLE AFTER IMPACTION. THE SURGICAL STEPS COMPLETED BY THE SURGEON WERE: DISCECTOMY, TRIAL, INSERT THE CAGE PARTIALLY, ROTATE THE CAGE 90 DEGREES, AND THEN IMPACT TO FINAL POSITION IT WAS NOTED BY THE REPORTER THAT THE PATIENT HAD VERY HARD BONE. THERE WAS NO HARM TO THE PATIENT AND THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757792 VALEO PLOL CAGE SYSTEM CAGE INSERTER TIP LXH CTL MEDICAL CORPORATION 91.113.6022F CC3AF/DDSAF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown