BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEZ SPINE LAGUNA PEDICLE SCREW SYSTEM

    MDR report key: 989845 · Received February 1, 2008

    Report

    Report Number
    3005032381-2008-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2008
    Report Date
    December 20, 2007
    Manufacturer
    ALLEZ SPINE, LLC
    Product Code
    MNI
    PMA / PMN Number
    K050060
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PEDICLE SCREW SYSTEM WAS IMPLANTED INTO THE PT IN 2006 FOR SPINAL FIXATION. DURING A RE-SURGERY FOR THE PURPOSE OF PEDICLE SUBSTRACTION OSTEOTOMY REQUIRING AN EXTENSION OF THE FUSION, THE LOCKING NUT ON THE RIGHT SIDE AT T-11 WAS DISCOVERED TO BE COMPLETELY DISENGAGED AND LOCKING NUT ON THE LEFT SIDE AT T-11 WAS FOUND TO BE LOOSE. THE REMAINDER OF THE CONSTRUCT WAS FOUND INTACT. THE STRYKER KIA SYSTEM WAS USED FOR RE-IMPLANTATION. NO OTHER COMPLICATIONS OR ADVERSE EFFECTS FROM THE DEVICE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEZ SPINE LAGUNA PEDICLE SCREW SYSTEM SPINAL FIXATION SYSTEM MNI ALLEZ SPINE, LLC 10467-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention