BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS OCT

    MDR report key: 3965508 · Received July 29, 2014

    Report

    Report Number
    1000432246-2014-00003
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    May 2, 2014
    Report Date
    July 26, 2014
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K121979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CHECKING THE COMPLIANCE OF THE RETURNED DEVICE WITH REQUIREMENTS IS PRACTICAL. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THE RESULTS OF TESTS PERFORMED ON THE DEVICE DURING ITS MANUFACTURING COMPLY WITH THE REQUIREMENTS. POLYAXIAL SCREW IMPLANTED ON C5 CERVICAL VERTEBRA. INSTRUCTIONS FOR USE WARNS THAT "THE USE OF THE POLYAXIAL SCREWS IS LIMITED TO PLACEMENT IN THE UPPER THORACIC SPINE (T1-T3) FOR ANCHORING THE OCT CONSTRUCT, AND IS NOT INTENDED TO TREAT THORACIC CONDITIONS. THE POLYAXIAL SCREWS ARE NOT INTENDED TO BE PLACED IN THE CERVICAL SPINE." NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE EVENT HAPPENED DURING A POSTERIOR CERVICAL STABILIZATION SURGERY WHEN PERFORMING THE FINAL NUT TIGHTENING. THE ENTIRE SCREW PART PULLED OUT.. THE THREADED PART OF THE SCREW AS WELL AS A CONNECTOR WERE LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442398 PASS OCT POSTERIOR SPINAL SYSTEM MNI MEDICREA INTERNATIONAL Ø3.5 MM X 18 MM 14B0522

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization