BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 925384 · Received October 9, 2007

    Report

    Report Number
    3005501497-2007-00009
    Event Type
    Injury
    Date Received
    October 9, 2007
    Date of Event
    August 23, 2007
    Report Date
    October 5, 2007
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE COMPANY FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED DEVICE DEMONSTRATED THAT THE MESH DEPLOYED INTO A SHAPE CONSISTENT WITH WHAT WOULD BE EXPECTED FOR THE ANATOMICAL SPACE TO WHICH IT WAS APPLIED. WE CAN ONLY CONCLUDE THAT THE DEVICE FAILED BY A KNOWN FAILURE MODE, DEFINED IN THE PACKAGE INSERT AS EXTRUSION.

    Description of Event or Problem · 1

    THE INCLOSE-GSM MESH WAS IMPLANTED IN 2007 FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L5/S1. THE PATIENT EXPERIENCED RECURRENT SYMPTOMS 4-6 WEEKS AFTER THE INITIAL SURGERY/IMPLANT PLACEMENT. MR IMAGING DEMONSTRATED THE APPEARANCE OF A RECURRENT DISC HERNIATION AT THE SAME LOCATION AS PREVIOUSLY TREATED. EXPLORATORY SURGERY WAS PERFORMED THE FOLLOWING MONTH. THE S1 NERVE ROOT WAS FOUND TO BE MARKEDLY DISPLACED BY AN UNDERLYING MASS, DETERMINED TO BE A LARGE HERNIATED DISC FRAGMENT. THE FRAGMENT WAS ADHERED TO THE INCLOSE MESH WHICH WAS ALSO REMOVED, INCLUDING ANCHORS AND SOME ADHERENT SCAR MATERIAL. A THOROUGH DECOMPRESSION WAS UNDERTAKEN AND ADDITIONAL LOOSE DISC MATERIAL WAS FOUND AND REMOVED. THE PATIENT WAS EXAMINED POSTOPERATIVELY AND NOTED TO BE AT HER BASELINE NEUROLOGICALLY. SHE DID NOTE THAT HER LEG PAIN WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCLOSE SURGICAL MESH SYSTEM SURGICAL MESH, POLYMERIC FTL ANULEX TECHNOLOGIES, INC INCLOSE-GSM 100030

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention