BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILLICO RETRACTOR (STAINLESS STEEL)

    MDR report key: 3820140 · Received May 20, 2014

    Report

    Report Number
    2027467-2014-00009
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE IS CURRENTLY BEING CONDUCTED. A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION. THE ILLICO MIS POSTERIOR FIXATION SYSTEM IS INTENDED TO FACILITATE THE SURGICAL CORRECTION OF NONCERVICAL SPINAL DEFORMITIES BY PROVIDING TEMPORARY INTERNAL FIXATION AND STABILIZATION DURING BONE GRAFT HEALING AND/OR FUSION MASS DEVELOPMENT. WHEN USED FOR A MINIMALLY INVASIVE POSTERIOR APPROACH ILLICO MIS INSTRUMENTATION IS USED IN CONJUNCTION WITH POLYAXIAL SCREW COMPONENTS. THE IMPLANTS ARE MANUFACTURED FROM SURGICAL GRADE TITANIUM ALLOY (B)(4). THE RODS ARE AVAILABLE IN COMMERCIALLY PURE (CP) TITANIUM AND/OR COBALT CHROME.

    Additional Manufacturer Narrative · 1

    THE FAILURE ANALYSIS CONCLUDED THE MOST LOGICAL CAUSE OF THE FAILURE APPEARS TO HAVE BEEN AN INSUFFICIENT INCISION LENGTH WHICH LED TO MUCH HIGHER SOFT TISSUE FORCES DURING RETRACTOR USE AND CAUSED THE MAIN RACK TO EXPERIENCE BENDING LOADS HIGH ENOUGH TO CRACK AND BREAK THE INSTRUMENT. BASED UPON THE FAILURE ANALYSIS, IT APPEARS THAT THE OVERLOAD SITUATION WAS CAUSED BY THE PRIMARY INCISION NOT BEING LARGE ENOUGH FOR THE RETRACTOR BLADES TO PROPERLY FIT IN THE UNOPENED CONFIGURATION, OR IF THE INCISION WAS NOT LARGE ENOUGH FOR THE RETRACTOR TO BE OPENED TO THE INTENDED LENGTH OF RETRACTION. IN THIS SCENARIO, THE BLADES WOULD IMMEDIATELY TRANSMIT INCREASED BENDING STRESSES TO THE MAIN RACK AS THE RETRACTOR WAS BEING OPENED. COMPLETE DETAILS ATTACHED IN EVALUATION SUMMARY. THE ILLICO RETRACTOR IS A MINIMALLY INVASIVE POSTERIOR THORACOLUMBAR ACCESS SYSTEM. INDEPENDENT BLADE RETRACTION CREATES A CUSTOMIZED ACCESS SITE WHILE INDIVIDUAL BLADE TOEING, OF UP TO 15 DEGREES, MINIMIZES SOFT TISSUE TRAUMA. TEN DIFFERENT BLADE LENGTHS ACCOMMODATE VARYING PATIENT ANATOMY AND THREE ATTACHMENT POSTS ON THE RETRACTOR AID TO MINIMIZE FLUOROSCOPIC OBSTRUCTION. THE ILLUMINATOR LIGHT SOURCE IS UNOBTRUSIVE AND SNAPS DIRECTLY ONTO THE BLADE PROVIDING EXCELLENT VISUALIZATION. A SUPPLEMENTAL 5TH BLADE IS AVAILABLE AND AN OPEN LATERAL WORKING CHANNEL ACCOMMODATES INSTRUMENT MANEUVERING DURING SURGICAL PROCEDURES.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER (B)(6) REPORTED THAT AN ILLICO RETRACTOR FRACTURED AND BROKE PRIOR TO COMPLETELY OPENING THE SURGICAL SITE. THE IRREGULARITY RENDERED THE DEVICE USELESS CAUSING THE SURGEON TO GO FROM MINIMALLY INVASIVE (MIS) TO AN OPEN PROCEDURE. THE EVENT CAUSED OVER A 30 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299152 ILLICO RETRACTOR (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 73520 48911

    Patients

    Seq Age Sex Outcome Treatment
    1 Other