BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1960980 · Received January 11, 2011

    Report

    Report Number
    3004485144-2011-00001
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    June 1, 2009
    Report Date
    December 13, 2010
    Manufacturer
    LANX, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, IT APPEARS THAT CONSTRUCT FATIGUE AND LACK OF PATIENT BONY FUSION CONTRIBUTED TO FAILURE OF THE RODS AT L5-S1 AND THE SCREW AT S1. INFORMATION FROM THE INITIAL REPORTER INDICATES THAT IN (B)(6) 2009, THE PATIENT WAS "RELEASED WITHOUT RESTRICTIONS AND RETURNED TO WORK". WHEN ATTEMPTING TO FIX A FLAT TIRE ON HIS COMPANY TRUCK, THE RODS IN HIS BACK SNAPPED. OPERATIVE NOTES FROM THE (B)(6) 2009 REVISION INDICATE THAT THE PATIENT HAD POOR BONY FUSION FROM T5 DOWN TO THE PELVIS FROM A PREVIOUS SURGERY PERFORMED ON (B)(6) 2008. THE PATIENT HAD UNDERGONE ANTERIOR/POSTERIOR SURGERY ON (B)(6) 2008, TO REMOVE PREVIOUSLY PLACED (B)(4) SPINAL INSTRUMENTATION FROM T12-L1 AND REPLACE WITH LANX INSTRUMENTATION FROM T5 TO THE PELVIS. LANX PEEK INTERBODY DEVICES WERE PLACED ANTERIORLY AT L2-L3, L3-L4, L4-L5, L5-S1. ALLOGRAFT, AUTOGRAFT, AND (B)(4) WAS USED T5 TO THE PELVIS. OPERATIVE NOTES FOR THE (B)(6) 2008 SURGERY DIAGNOSED THE PATIENT PREOPERATIVELY AS "LUMBAR PSEUDOARTHROSES STATUS POST PREVIOUS L1-S1 FUSION WITH RESULTANT FLAT-BACK DEFORMITY AND JUNCTIONAL KYPHOSES T12 TO L1". POSTOPERATIVE DIAGNOSIS WAS THE SAME.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A REVISION SURGERY TO REPLACE RODS THAT WERE FRACTURED AT L5-S1 BILATERALLY. OPERATIVE NOTES INDICATE THE SURGEON IDENTIFIED LOOSE PEDICLE SCREWS BILATERAL AT T5 AND A FRACTURED SCREW SHANK AT RIGHT S1. PREVIOUSLY IMPLANTED INSTRUMENTATION WAS REMOVED FROM T5 TO THE PELVIS. RE-INSTRUMENTATION WITH NEW RODS AND SCREWS WAS T6 TO THE PELVIS WITH INTERBODY FUSION FROM L5-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWQ LANX, INC. 7701-2500

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention DBM PUTTY| ALLOGRAFT| PEEK INTERBODY DEVICES| AUTOGRAFT