BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1971524 · Received January 24, 2011

    Report

    Report Number
    3004485144-2011-00006
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    September 22, 2009
    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 (B)(4) RESEARCH DEPT 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. EVAL, METHOD: NO DEVICES RETURNED, DEVICES REMAIN IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SPINAL FUSION AND DECOMPRESSION (LAMINECTOMY, FORAMINOTOMY) ON (B)(6) 2008 AT L4-L5 AND L5-S1. NO COMPLICATIONS WERE NOTED UNTIL (B)(6) 2009. RE-HERNIATION OF DISC OCCURRED. A MICRODISCECTOMY WAS PERFORMED AT L4-L5 WHICH HAD PREVIOUSLY BEEN FUSED WITH COMPONENTS. SOLID FUSION WAS EVIDENT THROUGH THE L4-L5 AND L5-S1 LEVELS. POSTEROLATERAL FUSION HAD ALSO TAKEN PLACE AT BOTH LEVELS. A KEYHOLE LAMINECTOMY WAS NEEDED TO DECOMPRESS THE LATERAL RECESS. NO COMPONENTS WERE REMOVED. THE PT CONTINUED TO REPORT PAIN FOLLOWING THE PROCEDURE. MEDICATION WAS ADMINISTERED AND CONSIDERED RESOLVED AS OF (B)(6) 2010.

    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 53 YR Required Intervention NEUROTONIN ADMINISTERED (B)(6) 2009 - (B)(6) 2010