BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    MDR report key: 4262861 · Received November 19, 2014

    Report

    Report Number
    3005031160-2014-00014
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 20, 2014
    Report Date
    November 18, 2014
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K131350
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE SENIOR REGISTRAR WAS PREPARING THE DISC SPACE FOR INSERTION OF THE TRIAL. HE INITIALLY STARTED WITH THE 8MM PADDLE SHAVER AND WORKED HIS WAY UP TO THE 12MM PADDLE SHAVER. WHILE USING THE 12MM PADDLE SHAVER THE NECK HAD BECOME BENT; THEREFORE, THE 11MM PADDLE SHAVER WAS USED TO CLEAR THE REST OF THE DISC SPACE. THE SENIOR REGISTRAR WAS FOLLOWING THE SURGICAL TECHNIQUE; HOWEVER, WHEN HE USED THE MALLET TO HAMMER THE 12MM TRIAL INTO PLACE, THE INSERTER TIP SNAPPED OFF IN THE 12MM TRIAL. HE REMOVED THE 12MM TRIAL AND INSERTER FROM THE DISC SPACE AND THEN SELECTED THE 11MM TRIAL AND ATTACHED IT TO ANOTHER INSERTER WHICH WAS OBTAINED FROM THE SET TRAY. ONCE AGAIN, HE USED THE MALLET TO HAMMER THE 11MM TRIAL INTO PLACE, WHEN THE TIP OF THE INSERTER BROKE OFF IN THE 11MM TRIAL. HE REMOVED THE 11MM TRIAL AND INSERTER FROM THE DISC SPACE AND THEN SELECTED THE 10MM TRIAL AND ATTACHED IT TO THE ALL-IN-ONE ROTATING INSERTER AND LOCKED THE INSERTER AT 0 DEGREES. HE HAD USED THE MALLET TO TAP ON THE INSERTER (10MM TRIAL ATTACHED) AND TO POSITION THE TRIAL WITH IN THE PATIENT'S DISC SPACE; HOWEVER, ONCE AGAIN THE TIP OF THE INSERTER HAD SNAPPED OFF IN THE 10MM TRIAL. HOWEVER, THE INSERTER STILL CONTAINED HALF OF A THREAD WHICH WAS LONG ENOUGH TO GRASP ONTO THE 10MM CALIX T PC CAGE AND DELICATELY PLACED IT INTO THE PATIENT'S DISK SPACE. THE INSERTER WAS REMOVED AND THE SURGEON USED THE STRAIGHT TAMP AND CURVED TAMP TO POSITION THE CAGE AS ANTERIOR AS POSSIBLE IN THE DISC SPACE. THE SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES AS A RESULT OF THE FOREGOING. THIS WAS THE 4TH CALIX-T PROCEDURE PERFORMED BY THE SURGEON. THE PATIENT DID NOT SUSTAIN ANY INJURIES FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749006 CALIX LUMBAR SPINAL IMPLANT SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR