BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALEO II LL INTERBODY FUSION SYSTEM

    MDR report key: 24945554 · Received April 21, 2026

    Report

    Report Number
    3009051741-2026-00006
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 21, 2026
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    MAX
    PMA / PMN Number
    K121892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT OCCURRED IN SURGERY AND ALL BROKEN PIECES WERE EXTRACTED AND CONFIRMED ON X-RAY. NO INJURY TO THE PATIENT OCCURRED BUT THERE WAS A SIGNIFICANT DELAY IN SURGERY (20 MINUTES). BASED ON A MEETING WITH THE SUBJECT SALES REP REGARDING THE CASE, IT WAS NOTED THAT THE DISC SPACE WAS TIGHT AND REQUIRED SIGNIFICANT STRIKING FORCE TO ADVANCE. AFTER INSPECTING THE SUBJECT CAGE, THE IMPLANT CRACKED AT THE PROXIMAL END, SPLITTING THE THREAD CHANNEL. DUE TO THE LOCALIZED FAILURE OF THE SUBJECT CAGE AND THE DAMAGE SUSTAINED ON THE THREADS OF THE INSERTER, IT CAN BE CONCLUDED THAT THE IMPLANT WAS IMPROPERLY SECURED TO THE INSERTER (NOT THREADED COMPLETELY). BASED ON THE CONDITION OF THE DISTAL TIP THREADS OF THE INNER SHAFT (STRIPPED), THE IMPLANT WOULD NEVER BE ABLE TO FULLY ENGAGE THE THREADS. THE PITCH OF THE INNER SHAFT HAS WORN DOWN ENOUGH FROM REPEATED USE TO CAUSE SLIPPING WHEN DRAWING THE CAGE IMPLANT TIGHT TO THE INSERTER. WHEN THE IMPLANT IS NOT INSTALLED COMPLETELY ONTO THE INSERTER, ALL OF THE FORCE EXPERIENCED WHEN MALLETING IS CONCENTRATED AT THE POINT WHERE THE INNER SHAFT HAS ENGAGED THE THREADS OF THE CAGE. THIS CREATES LOCALIZED STRESSES THAT CAN EXCEED THE MATERIAL STRENGTH OF THE CAGE AFTER REPEATED STRIKING IN COMBINATION WITH THE TIGHT DISC SPACE. ROOT CAUSE THEREFORE IS WEAR AND TEAR DUE TO THE DISTAL TIP THREADS NOT EFFECTIVELY BEING ABLE TO DRAW THE CAGE IMPLANT TIGHTLY. NOTE: TWO CAGES BROKE IN THE SAME CASE, SEE MDR 3009051471-2026-00005.

    Description of Event or Problem · 0

    SURGEON INSERTED THE CAGE AND GOT IT INTO THE DISC SPACE, THEN IT BROKE WHILE MALLETING. THE PIECES WERE REMOVED AND THEY LEFT THE INTACT CAGE IN THE DISC SPACE. THEY CONFIRMED WITH X-RAY AFTERWARDS THAT EVERYTHING WAS REMOVED. THERE WAS A 20 MINUTE DELAY TO SURGERY; NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574694 VALEO II LL INTERBODY FUSION SYSTEM CAGE MAX CTL MEDICAL CORPORATION 11.020.3508 903757/FB5AA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown