BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX POSTERIOR CERVICOTHORACIC SYSTEM

    MDR report key: 2094547 · Received April 11, 2011

    Report

    Report Number
    3004485144-2011-00034
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 23, 2011
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RETURNED SCREW DRIVER AND DISASSEMBLED IMPLANT INDICATED THAT A DEFORMED TIP OF THE SCREW DRIVER CAUSED THE INSTRUMENT TO GRASP THE IMPLANT IN A MANNER THAT RESULTED IN COMPONENT DISLODGE. VISUAL INSPECTION OF THE INSTRUMENT INDICATES DEFORMATION TO THE TIP CAUSED FROM DAMAGE SUSTAINED DURING REPEATED USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW DRIVER DID NOT WANT TO FULLY DISENGAGE FROM THE HEAD OF THE POSTERIOR CERVICAL POLYAXIAL SCREW. THE INNER COMPONENT OF THE IMPLANT DISENGAGED DURING USE AS THE SURGEON ATTEMPTED TO REMOVE THE DRIVER. SURGERY WAS EXTENDED BY 20 MINUTES TO REMOVE THE SCREW COMPONENTS AND REPLACE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX POSTERIOR CERVICOTHORACIC SYSTEM POLYAXIAL SCREW DRIVER MNI LANX, INC. 7923-2001 LX-2642

    Patients

    Seq Age Sex Outcome Treatment
    1 POLYAXIAL SCREW: (B)(4)