BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMOUNT POLYAXIAL HEAD 3

    MDR report key: 1006332 · Received February 27, 2008

    Report

    Report Number
    3005559743-2008-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 26, 2008
    Manufacturer
    INNOVATIVE SPINAL TECHNOLOGIES, INC. (IST)
    Product Code
    MNI
    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 NOT RETURNED TO THE MFR BECAUSE IT WAS DISCARDED AT THE HOSP.

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED IST PARAMOUNT PEDICLE SCREWS AND POLYAXIAL HEAD 3S FROM L2 TO S1. LOCKING CAPS WERE SUCCESSFULLY TIGHTENED ON ALL POLYAXIAL HEAD 3S EXCEPT L5. DURING FINAL TIGHTENING OF THE LOCKING CAP AT L5, WHICH WAS THE LAST LOCKING CAP TO BE TIGHTENED, THE POLYAXIAL HEAD 3 BROKE. THE SURGEON REMOVED THE BROKEN PIECE BUT CHOSE NOT TO REMOVE THE IMPLANTED PORTION OF THE BROKEN POLYAXIAL HEAD 3. THIS RESULTED IN A FINAL CONSTRUCT ON THE LEFT SIDE THAT WAS LOCKED DOWN AT L2, L3, L4, AND S1. THE RIGHT SIDE CONSTRUCT WAS IMPLANTED WITHOUT INCIDENT WITH PEDICLE SCREWS AT L2, L3, L5, AND S1, SPANNING L4.

    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)

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention PARAMOUNT PEDICLE SCREW| PARAMOUNT POLYAXIAL HEAD 3| PARAMOUNT LOCKING CAP| PARAMOUNT ROD