BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMOUNT POLYAXIAL HEAD 3

    MDR report key: 938382 · Received November 5, 2007

    Report

    Report Number
    3005559743-2007-00006
    Event Type
    Malfunction
    Date Received
    November 5, 2007
    Date of Event
    October 8, 2007
    Report Date
    November 5, 2007
    Manufacturer
    INNOVATIVE SPINAL TECHNOLOGIES INC
    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

    L5 - S1, UNILATERAL MINI-OPEN PROCEDURE. THE SURGEON PLACED A 25MM ROD INTO THE POLYAXIAL HEAD 1 AT L5 AND THE POLYAXIAL HEAD 3 AT S1. CROSS THREADING OF THE S1 LOCKING CAP OCCURRED DURING FINAL TIGHTENING. IT WAS SUGGESTED THAT THE SURGEON USE THE 1ST LOCKING CAP STARTER AND 1ST COUNTER TORQUE TUBE TO FACILITATE LOCKING CAP ALIGNMENT, BUT THE SURGEON DECLINED. THE SURGEON CONTINUED WITH FINAL TIGHTENING, DURING WHICH THE POLYAXIAL HEAD 3 AT S1 BROKE. THE PEDICLE SCREW AND BROKEN POLYAXIAL HEAD 3 AT S1 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 MNI INNOVATIVE SPINAL TECHNOLOGIES INC 21933

    Patients

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