BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JULIET LL ANGLED CAGE + PLATE INSERTER

    MDR report key: 24302895 · Received February 10, 2026

    Report

    Report Number
    3007728266-2026-00004
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    January 12, 2026
    Manufacturer
    SPINEART SA
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WE RECEIVED ON JANUARY 13TH, 2026 AN EMAIL FROM THE FIELD REPORTING A PRODUCT COMPLAINT. THE DESCRIPTION OF THE EVENT IS AS FOLLOWING: WE USED THE ANGLED CAGE AND PLATE INSERTER ITEM JLL-IN 38 01-N TOGETHER WITH THE INNER SHAFT JLL-IN 07 02- N/B AS PER SURGICAL TECH SET UP DESCRIPTION. THE PLATE WAS SECURED INTO THE CAGE FIRST AND LOADED ON THE INSERTER. CAGE WAS PERFECTLY PLACED. THE SURGEON STARTED TO ROTATE THE INNER SHAFT TO TAKE THE INSERTER AWAY BUT IT WON'T DESINGAGE. THEN THE TOP PART OF THE INNER SHAFT CAME LOOSE BUT THE REST OF THE SHAFT WAS STILL DOWN THE INSERTER CHANNEL. A SPRING WAS FOUND IN THE WOUND ALSO. WHICH I BELIEVE TO BE PART OF THE INNER SHAFT. WE HAD TO TAKE THE CAGE OFF AND LOAD A NEW CAGE AND PLATE ON THE STRAIGHT INSERTER TO COMPLETE THE OPERATION. ACCORDING TO THE INFORMATION RECEIVED ON (B)(6) 2026, THE SPRING WAS TAKEN OUT OF THE PATIENT. THE SURGICAL DELAY LASTED AROUND 1 HOUR TO THE CASE AS THEY TRIED FEW THINGS TO DISENGAGE THE INSERTER FROM THE PATIENT, THEN THEY HAD TO TAKE THE CAGE OUT WITH THE INSERTER AND TRIAL A DIFFERENT SIZE. FOR THE MOMENT, WE DID NOT YET RECEIVE THE CONFIRMATION OF THE BATCH NUMBER OF THE INSTRUMENTS INVOLVED AND THE INSTRUMENTS ARE NOT RETURNED YET. AS SOON AS WE RECEIVE THE INSTRUMENTS, THE INVESTIGATION WILL BE STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570840 JULIET LL ANGLED CAGE + PLATE INSERTER JULIET LL ANGLED CAGE + PLATE INSERTER MAX SPINEART SA 5-9256

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female