BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMOUNT POLYAXIAL HEAD 3

    MDR report key: 935923 · Received October 31, 2007

    Report

    Report Number
    3005559743-2007-00004
    Event Type
    Malfunction
    Date Received
    October 31, 2007
    Date of Event
    October 3, 2007
    Report Date
    October 31, 2007
    Manufacturer
    INNOVATIVE SPINAL TECHNOLOGIES INC. (IST)
    Product Code
    MNI
    PMA / PMN Number
    K053276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY UNDER EVALUATION.

    Description of Event or Problem · 1

    SURGEON IMPLANTED FOUR 6.50MM X 50 MM PEDICLE SCREWS WITH POLYAXIAL HEADS UNILATERALLY FROM L2 - L5. AN 80MM ROD WAS SELECTED AND PLACED IN THE POLYAXIAL HEADS. A LOCKING CAP WAS THEN DELIVERED INTO EACH POLYAXIAL HEAD AND PROVISIONALLY TIGHTENED USING A FREE-HAND TECHNIQUE (WITHOUT IST COUNTER TORQUE TUBE). FINAL TIGHTENING OF L3 AND L4 LOCKING CAPS WAS THEN PERFORMED WITHOUT ISSUE USING IST COUNTER TORQUE TUBE AND LOCKING CAP DRIVER. AS SURGEON PERFORMED TIGHTENING OF L2 LOCKING CAP, AN AUDIBLE SNAP WAS HEARD. THE POLYAXIAL HEAD HAD BROKEN NEAR THE TOP OF THE DEVICE. SURGEON REMOVED BROKEN POLYAXIAL HEAD, REPLACED IT, AND COMPLETED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMOUNT POLYAXIAL HEAD 3 ORTHOSIS, SPINAL PEDICLE FIXATION MNI INNOVATIVE SPINAL TECHNOLOGIES INC. (IST) 21933

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention IST PARAMOUNT BENT ROD| IST PARAMOUNT POLYAXIAL HEAD 3| IST PARAMOUNT LOCKING CAP| IST PARAMOUNT PEDICLE SCREW