BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX FUSION SYSTEM

    MDR report key: 2479167 · Received February 24, 2012

    Report

    Report Number
    3004485144-2012-00009
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 6, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MAX
    PMA / PMN Number
    102738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL #: 8516-4520. THE INITIAL RPTR INDICATED NO STRIPPING OF THE SCREW OCCURRED. HE INDICATED THERE WAS NO NOTED ISSUE WITH THE SCREWS, PLATE OR INSTRUMENTS. THE SURGEON USED AN AWL TO PREPARE THE BONE AND A SOLID TIP U-JOINT DRIVER TO ATTEMPT TO DRIVE THE SCREWS. HARD BONE WAS THE LIKELY CAUSE AS INDICATED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES NO DISCREPANCIES WHICH WOULD HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE SURGEON ATTEMPTED TO IMPLANT FIVE SCREWS DURING AN ANCHORED ALIF SURGERY AT L5-S1. WHEN ATTEMPTING TO INSERT THE SCREWS INTO THE PLATE, HARD BONE PREVENTED THE SURGEON FROM BEING ABLE TO FULLY DRIVE THE SCREW. AS A RESULT, SCREWS FROM A SYNTHES IMPLANT SYSTEM WERE USED DURING IMPLANTATION OF THE LANX ANCHORED INTERBODY. THE SURGERY WAS COMPLETED W/O FURTHER INCIDENT WITH NO SIGNIFICANT DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX LANX, INC. 8516-4525 L550061

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR