BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMOUNT POLYAXIAL HEAD 3

    MDR report key: 937066 · Received November 2, 2007

    Report

    Report Number
    3005559743-2007-00005
    Event Type
    Malfunction
    Date Received
    November 2, 2007
    Date of Event
    October 3, 2007
    Report Date
    November 2, 2007
    Manufacturer
    INNOVATIVE SPINAL TECHNOLOGIES, INC. (IST)
    Product Code
    MNI
    PMA / PMN Number
    K053276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    L3 - L5, BILATERAL OPEN PROCEDURE. ALL SCREWS WERE IMPLANTED WITHOUT INCIDENT. SURGEON PLACED A 45MM ROD ON PATIENT'S LEFT SIDE AND SUCCESSFULLY TIGHTENED LOCKING CAPS AT L3 AND L4. WHEN HE TIGHTENED THE L5 LOCKING CAP, A SIDE OF THE POLYAXIAL HEAD 3 (PH3) BROKE. SURGEON REMOVED THE BROKEN PIECE AND THEN REMOVED THE BROKEN PH3 FROM THE SCREW. HE DECIDED TO REMOVE THE L5 SCREW AND DID NOT REPLACE IT. HE REPLACED THE 45MM ROD WITH A 25MM ROD, RESULTING IN A FINAL LEFT SIDE CONSTRUCT OF L3 - L4. A 45MM ROD WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE AT L3 - L5 WITH NO ISSUES.

    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) 18714

    Patients

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