BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX ANCHORED ALIF SCREW

    MDR report key: 2248185 · Received August 25, 2011

    Report

    Report Number
    3004485144-2011-00052
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 8, 2011
    Manufacturer
    LANX, INC.
    Product Code
    MQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER INDICATED THAT THE SCREWS WERE ATTEMPTED TO BE DRIVEN AT A DIFFICULT ANGLE, POSSIBLY CONTRIBUTING TO THE STRIPPING. HARD BONE AT S1 MAY HAVE ALSO CONTRIBUTED. A REVIEW OF THE DHR INDICATES THAT NO DISCREPANCIES WERE NOTED WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE, FIVE SCREWS WERE STRIPPED DURING ATTEMPTED INSERTION AT S1. A 35 MINUTES SURGICAL DELAY OCCURRED. ONLY TWO OF FOUR SCREWS WERE PLACED, NO SCREWS WERE PLACED AT S1. THE INITIAL REPORTER INDICATED THAT THE SCREWS WERE ATTEMPTED TO BE PLACED AT A DIFFICULT ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX ANCHORED ALIF SCREW ANCHORED ALIF SCREW MQP LANX, INC. 8503-5025 L537194A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention