BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1800030 · Received August 11, 2010

    Report

    Report Number
    3004485144-2010-00042
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Report Date
    July 23, 2008
    Manufacturer
    LANX, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ORIGINAL LUMBAR SPINAL FIXATION SURGERY USING LANX RODS/SCREWS WAS PERFORMED ON AN UNKNOWN DATE. A REVISION SURGERY WAS PERFORMED FOR ADDITIONAL FUSION AT A LEVEL ABOVE THE ORIGINAL CONSTRUCT ON (B)(6) 2008. THE INDENTED APPROACH OF THE REVISION SURGERY WAS REMOVAL OF THE ORIGINAL ROD/SCREW CONSTRUCT, ALTHOUGH NO INFORMATION PROVIDED SUGGESTED A MALFUNCTION OF THE ORIGINAL CONSTRUCT. BECAUSE THE SCREW COULD NOT BE REMOVED AS ORIGINALLY PLANNED, THE SURGERY WAS COMPLETED BY UTILIZING THE PREVIOUSLY IMPLANTED SCREWS, THE ADDITION OF LANX PEDICLE SCREWS AND SET SCREWS AT THE LEVEL ABOVE THE ORIGINAL CONSTRUCT AND THE USE OF ANOTHER MANUFACTURER'S ROD FOR FIXATION. THE SURGEON CHOSE TO UTILIZE ANOTHER MANUFACTURER'S ROD TO COMPLETE THE CONSTRUCT, EVEN THOUGH THE LANX SYSTEM PROVIDES A COMPLETE SELECTION OF RODS TO ACCOMMODATE THE PROCEDURE. THIS EVENT IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF THE COMPANY'S COMPLAINT RECORDS. THE COMPANY HAS RECENTLY RE-EVALUATED THIS EVENT BASED ON NEW INFORMATION AND HAS DETERMINED THAT THE EVENT MAY BE MDR REPORTABLE. ACCORDINGLY, THE COMPANY IS SUBMITTING THE REPORT IN AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE. INFORMATION REGARDING USE OF DEVICE UNKNOWN, NO DEVICE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A REVISION PROCEDURE, A BROKEN TINE FROM THE BONE DRIVER PREVENTED REMOVAL OF THE ORIGINALLY IMPLANTED SCREW. THE BROKEN TINE COULD NOT BE RECOVERED AND REMAINED IN THE SCREW AFTER COMPLETION OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM BONE DRIVER - SPINAL FIXATION SYSTEM NKB LANX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1