BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1971544 · Received January 24, 2011

    Report

    Report Number
    3004485144-2011-00007
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    August 13, 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 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. NO DEVICE RETURNED. SUMMARY OF PT FOLLOW-UP VISITS: ON (B)(6) 2009 - PT UNDERWENT WOUND DRAINAGE. RESOLVED WITH NO RESIDUAL EFFECTS. ON (B)(6) 2009 - POST-OPERATIVE RADICULAR LEFT LEG PAIN WAS NOTED, WHICH WAS RESOLVED WITH MEDICATION AND NO RESIDUAL EFFECTS. ON (B)(6) 2009 - PT DEVELOPED PAIN AT LEVEL ABOVE IMPLANTED LEVEL (L3-4). SURGERY PERFORMED (B)(6) 2009. ON (B)(6) 2009 - ASPEN HARDWARE WAS REMOVED IN ORDER TO PERFORM A DECOMPRESSION AT THAT LEVEL. ADDITIONALLY, A DECOMPRESSIVE HEMILAMINECTOMY AND FUSION WAS PERFORMED AT L3-4 FOR WORSENING SPINAL STENOSIS AT THAT LEVEL. ONSET DUE TO STRENUOUS ACTIVITY. ON (B)(6) 2010 - PT DEVELOPED NERVE ROOT PAIN AT PREVIOUSLY FUSED AND DECOMPRESSED LEVEL (4-5). PAIN WAS A RESULT OF LARGE EXTRUDED DISC. SURGERY PERFORMED (B)(6) 2010. ON (B)(6) 2010 - A MICRODISCECTOMY WAS L4-5 AND A HARDWARE REMOVAL AT L3-4 WAS PERFORMED IN ORDER TO ACCOMPLISH THE MICRODISCECTOMY. ADEQUATE FUSION OF L3-4 HAD TAKEN PLACE AND WAS NOTED INTRAOPERATIVELY.

    Description of Event or Problem · 1

    THE PT UNDERWENT SPINAL FUSION, DISCECTOMY AND DECOMPRESSION (LAMINOTOMY) ON (B)(6) 2009, AT THE L4-L5 LEVEL. ON (B)(6) 2009, HARDWARE WAS REMOVED IN ORDER TO PERFORM A DECOMPRESSION AT THE L4-5 LEVEL AS A RESULT OF DISEASE PROGRESSION. ADDITIONALLY, A DECOMPRESSIVE HEMILAMINECTOMY AND FUSION WAS PERFORMED AT L3-4 FOR WORSENING SPINAL STENOSIS AT THAT LEVEL. ONSET OCCURRED WITH STRENUOUS ACTIVITY. PT FURTHER DEVELOPED NERVE ROOT PAIN AT PREVIOUSLY FUSED AND DECOMPRESSED LEVEL (L4-5). PAIN WAS A RESULT OF LARGE EXTRUDED DISC. SURGERY PERFORMED (B)(6) 2010. A MICRODISCECTOMY AT L4-5 AND A HARDWARE REMOVAL AT L3-4 WAS PERFORMED IN ORDER TO ACCOMPLISH THE MICRODISCECTOMY. ADEQUATE FUSION OF L3-4 HAD TAKEN PLACE AND WAS NOTED INTRAOPERATIVELY.

    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 54 YR Required Intervention MEDROL PACK, 4MG| LORTAB 7.5| KEFLEX| FLEXERIL