BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMOUNT POLYAXIAL HEAD 3

    MDR report key: 1006293 · Received February 25, 2008

    Report

    Report Number
    3005559743-2008-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 25, 2008
    Manufacturer
    INNOVATIVE SPINAL TECHNOLOGIES INC. (IST)
    Product Code
    MNH
    PMA / PMN Number
    K053276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND IS CURRENTLY UNDER EVAL. A PRECAUTION IS STATED IN THE INSTRUCTIONS FOR USE THAT ACCOMPANY THIS DEVICE; "TO ACHIEVE THE BEST RESULTS, DO NOT USE THE IST PEDICLE SCREW SYS WITH COMPONENTS FROM ANY OTHER SYS OR MFR."

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED IST PARAMOUNT PEDICLE SCREWS AND POLYAXIAL HEAD 3S FROM L4 TO S1. HE THEN CONNECTED THE POLYAXIAL HEAD 3S WITH A SCIENT'X DYNAMIC TTL ROD. WHILE ATTEMPTING TO TIGHTEN THE IST LOCKING CAP ONTO THE L5 POLYAXIAL HEAD 3, THE POLYAXIAL HEAD 3 BROKE. THE PEDICLE SCREW AND BROKEN POLYAXIAL HEAD 3 AT L5 WERE REMOVED AND REPLACED. FINAL LOCKDOWN WAS ACHIEVED SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCIENT'X DYNAMIC TTL ROD| PARAMOUNT PEDICLE SCREW| PARAMOUNT LOCKING CAP| PARAMOUNT POLYAXIAL HEAD 3