BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX FUSION SYSTEM

    MDR report key: 2890985 · Received December 20, 2012

    Report

    Report Number
    3004485144-2012-00043
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 3, 2012
    Manufacturer
    LANX, INC.
    Product Code
    MAX
    PMA / PMN Number
    102738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NON-IMPLANTED PORTION OF THE BROKEN INSTRUMENT WAS RETURNED AND VISUALLY INSPECTED, AND THE BREAKAGE WAS CONFIRMED. THE AVAILABLE INFORMATION SUGGESTS THAT SURGEON DID NOT FOLLOW INSTRUCTIONS PROVIDED WITHIN THE SURGICAL TECHNIQUE GUIDE, AND THIS LED TO AN EXCESSIVE APPLICATION OF FORCE TO AN INSTRUMENT NOT DESIGNED FOR SUCH LOADING. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THERE IS NO EVIDENCE TO INDICATE THAT THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    THE SCREWDRIVER TIP BROKE OFF WITHIN THE SCREW HEAD DURING SCREW INSERTION. AFTER A FAILED ATTEMPT TO REMOVE THE DRIVER TIP, THE SURGEON PLACED THE COVER PLATE OVER THE SCREW HEAD, TRAPPING THE TIP WITHIN THE DEVICE. THERE WAS NO PATIENT INJURY RESULTING FROM THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX FUSION SYSTEM INTERVERTEBRAL BODY FUSION DEVICE MAX LANX, INC. 8530-1001 L570278

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW COMPONENT: 8524-XXXX