BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 1365114 · Received April 17, 2009

    Report

    Report Number
    3005501497-2009-00002
    Event Type
    Injury
    Date Received
    April 17, 2009
    Date of Event
    October 18, 2007
    Report Date
    April 17, 2009
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE INCLOSE MESH WAS IMPLANTED IN 2007, FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L5-S1. THE PT RETURNED TO THE CLINIC ONE MONTH LATER WITH RECURRENT LEFT S1 RADICULOPATHY. EXPLORATORY SURGERY WAS PERFORMED THE FOLLOWING MONTH. AFTER REMOVAL OF RECURRENT DISC EXTRUSION, THE MESH WAS FOUND PARTIALLY EXTRUDED FROM THE DISC SPACE AND DID NOT APPEAR TO BE SECURED TO THE ANULUS ON THE LATERAL SIDE OF THE REPAIR SITE. THE MESH WAS REMOVED AND AGGRESSIVE DISCECTOMY WAS PERFORMED UNTIL THE DISC SPACE WAS LARGELY EMPTIED. THE PT WAS DISCHARGED THE FOLLOWING DAY WITHOUT COMPLICATIONS. THE PT WAS LAST SEEN ON A REFERRAL IN 2009, DUE TO SYMPTOMS RELATING TO A POSSIBLE RIGHT L4 RADICULOPATHY, HOWEVER, COMPARISON TO PREVIOUS RECORDS INDICATED LITTLE CHANGE IF ANY. A NON-SURGICAL COURSE OF TREATMENT WAS RECOMMEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCLOSE SURGICAL MESH SYSTEM SURGICAL MESH, POLYMERIC FTL ANULEX TECHNOLOGIES, INC INCLOSE-XR 100347

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention