BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX POLYAXIAL PEDICLE SCREW

    MDR report key: 590098 · Received April 8, 2005

    Report

    Report Number
    3003807094-2005-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2005
    Date of Event
    March 9, 2005
    Report Date
    April 8, 2005
    Manufacturer
    SCIENT'X USA, INC.
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THREE PEDICLE SCREWS FRACTURED DURING FINAL TIGHTENING ONTO A LONGITUDINAL ROD. TWO OD THE FRACTURED SCREWS WERE REMOVED AND REPLACED WITH A NEW SCREWS WITHOUT INCIDENT. THE THIRD FRACTURED SCREW WAS REMOVED BUT NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MX POLYAXIAL PEDICLE SCREW PEDICLE SCREW MNH SCIENT'X USA, INC. * US064L

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other