BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX POSTERIOR CERVICOTHORACIC FIXATION SYSTEM

    MDR report key: 2152383 · Received June 22, 2011

    Report

    Report Number
    3004485144-2011-00043
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 31, 2011
    Manufacturer
    LANX, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE INSPECTION RECORDS FOR THE TURRET SCREW OR DRIVERS INDICATES THAT NO DISCREPANCIES WERE NOTED WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A POSTERIOR CERVICAL CASE, TWO TURRET SCREW DRIVERS WERE BROKEN DURING PLACEMENT OF A TURRET SCREW. THE SCREW WAS SUCCESSFULLY REMOVED AND REPLACED WITH A STANDARD POLYAXIAL SCREW. A 20 MINS SURGICAL DELAY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX POSTERIOR CERVICOTHORACIC FIXATION SYSTEM TURRET SCREW KWP LANX, INC. 7915-4028 L533963

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TURRET SCREW DRIVER: 7935-1001, L533983 QTY 2