BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 929891 · Received October 18, 2007

    Report

    Report Number
    3005501497-2007-00011
    Event Type
    Injury
    Date Received
    October 18, 2007
    Date of Event
    September 10, 2007
    Report Date
    October 15, 2007
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. IT IS UNCLEAR WHETHER THE PATIENT'S SYMPTOMS WOULD HAVE RESOLVED WITH DECOMPRESSION ALONE. NO CONCLUSION CAN BE DRAWN WITH REGARD TO WHETHER THE DEVICE CONTRIBUTED TO THE ADVERSE EVENT THAT NECESSITATED REVISION SURGERY.

    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 DID WELL INITIALLY, BUT EXPERIENCED RECURRENT SYMPTOMS 3 WEEKS FOLLOWING THE INITIAL PROCEDURE. EXPLORATORY SURGERY WAS PERFORMED ON THE FOLLOWING MONTH, AT WHICH TIME IT WAS NOTED THAT THE INCLOSE MESH WAS FIXED IN THE LOCATION THAT IT WAS ORIGINALLY PLACED (BELOW THE TISSUE OF THE ANULUS FIBROSUS). FURTHER EXAMINATION IDENTIFIED A RE-HERNIATION LATERAL TO WHERE THE MESH WAS PLACED. ADDITIONAL DECOMPRESSION WAS PERFORMED AT WHICH TIME THE SURGEON ALSO REMOVED THE MESH. A DURAL TEAR OCCURRED DURING THE PROCEDURE AND WAS REPAIRED INTRAOPERATIVELY. THERE WERE NO CONTINUING ADVERSE EFFECTS.

    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 100111

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention