BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX FUSION SYSTEM

    MDR report key: 3201666 · Received June 28, 2013

    Report

    Report Number
    3004485144-2013-00019
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 28, 2013
    Manufacturer
    LANX, LLC
    Product Code
    MAX
    PMA / PMN Number
    103666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A LANX FUSION PROCEDURE, BOTH THE TOEING SCREW OF THE RETRACTOR AND THE BLADE ATTACHMENT SCREW BECAME STRIPPED. AFTER COMPLETING THE TRIALING STAGE OF THE PROCEDURE AND DURING ATTEMPTED TRIAL REMOVAL, THE TRIAL BECAME STUCK BEHIND ONE OF THE BLADES. DUE TO THE STRIPPED SCREWS, THE SURGEON WAS FORCED TO REMOVE THE ENTIRE RETRACTOR SETUP TO REMOVE THE TRIAL. THIS RESULTED IN A 20 MINUTE DELAY IN THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE USER OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297042 LANX FUSION SYSTEM RETRACTOR AND RETRACTOR BLADE MAX LANX, LLC 8734-0010, 8734-2150 L562888, L561271

    Patients

    Seq Age Sex Outcome Treatment
    1