BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1971546 · Received January 24, 2011

    Report

    Report Number
    3004485144-2011-00008
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    May 7, 2010
    Report Date
    November 18, 2010
    Manufacturer
    LANX, INC
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS DISCOVERED DURING A RETROSPECTIVE REVIEW OF CASE REPORT FORMS BY THE (B)(4) RESEARCH DEPARTMENT BETWEEN (B)(6) 2010 AND (B)(6) 2010. THE EVENT WAS FORWARDED TO APPROPRIATE PERSONNEL ON (B)(4) 2010, FOR COMPLAINT/MDR DETERMINATION AFTER COMPLETION OF THE REVIEW. IMPLANTATION OF COMPONENTS AT MULTIPLE LEVELS WAS 510K APPROVED AT THE TIME OF IMPLANTATION. NO DEVICES RETURNED, DEVICES REMAIN IMPLANTED. PT FOLLOW-UP HISTORY: ON (B)(6) 2009 - PT COMPLAINED OF NECK PAIN, HEADACHES, SCALP TENDERNESS AND BLURRED VISION (ALL LEFT-SIDED). ON (B)(6) 2010 - PT REPORTED NEW LEG PAIN, RIGHT SIDE, ASSOCIATED WITH A STUMBLE AND INCREASED ACTIVITY. ON (B)(6) 2010 - A RIGHT SIDED MINIMALLY INVASIVE MICRODISCECTOMY WAS PERFORMED AS WELL AS FORAMINOTOMY AND LATERAL RECESS DECOMPRESSION AT L5-S1. NO REMOVAL OF THE COMPONENTS WAS PERFORMED.

    Description of Event or Problem · 1

    THE PT UNDERWENT SPINAL FUSION AND DECOMPRESSION (LAMINECTOMY) ON (B)(6) 2009, AT THE L2-3, L3-4, L4-5 AND L5-S1 LEVELS. ON (B)(6) 2010, A RIGHT SIDED MINIMALLY INVASIVE MICRODISCECTOMY WAS PERFORMED AS WELL AS FORAMINOTOMY AND LATERAL RECESS DECOMPRESSION AT L5-S1. NO REMOVAL OF THE COMPONENTS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINOUS PROCESS FUSION PLATE NKB LANX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention