BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1971554 · Received January 24, 2011

    Report

    Report Number
    3004485144-2011-00014
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    December 3, 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 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. SPECIFIC CAUSE OF REVISION UNK. ADD'L PT F/U: ON (B)(6) 2008 - PT REPORTED ECCHYMOSIS OVER BUTTOCK. ON (B)(6) 2008 - BRONCHITIS, (B)(6) 2008 - RIGHT POSTERIOR THIGH PAIN, (B)(6) 2008 - PNEUMONIA, (B)(6) 2009 - RIGHT KNEE PAIN, (B)(6) 2009 - SACRAL PAIN, PT UNDERWENT RIGHT KNEE ARTHROPLASTY SINCE LAST VISIT, (B)(6) 2009 - POSTERIOR THIGH PAIN RADIATING THROUGH BUTTOCKS TO LEVEL OF KNEES, (B)(6) 2009 - RECURRENT DISC HERNIATION L4-5, (B)(6) 2009 - REMOVAL OF NONSEGMENTAL INSTRUMENTATION (PLATES (L3-4, L4-5). REVISION OF L3-4, L4-5, L5-S1 BILATERAL FORAMINOTOMIES AND MEDIAL FACETECTOMIES WAS PERFORMED. TRANSFORAMINAL INTERBODY FUSIONS AND POSTERIOR SPINAL FUSIONS WERE PERFORMED AT L3-4 AND L4-5 USING ANOTHER MFR'S INTERBODY COMPONENT AND ALLOGRAFT, (B)(6) 2010 - INCREASED LOWER BACK PAIN, SINGLE EPISODE.

    Description of Event or Problem · 1

    PT UNDERWENT SPINAL FUSION AND DECOMPRESSION (FORAMINOTOMY, MICRODISCECTOMY) ON (B)(6) 2008 AT THE L3-4 AND L4-5 LEVELS. ON (B)(6) 2009, THE PT UNDERWENT ANOTHER SURGERY FOR REMOVAL OF INTERSPINOUS FIXATION PLATES AT L3-L4, L4-5. THE REVISION CONSISTED OF L3-4, L4-5, L5-S1 BILATERAL FORAMINOTOMIES AND MEDIAL FACETECTOMIES WERE PERFORMED. TRANSFORAMINAL INTERBODY FUSIONS AND POSTERIOR SPINAL FUSIONS WERE PERFORMED AT L3-4 AND L4-5 USING ANOTHER MFR'S INTERBODY, FIXATION COMPONENTS AND ALLOGRAFT.

    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 PERCOCET