BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 870444 · Received June 20, 2007

    Report

    Report Number
    3005501497-2007-00007
    Event Type
    Injury
    Date Received
    June 20, 2007
    Date of Event
    May 22, 2007
    Report Date
    June 20, 2007
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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-RM MESH WAS IMPLANTED IN 2006, FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L5/S1. IN 2007, THE PATIENT EXPERIENCED ACUTE RECURRENCE OF SYMPTOMS. AN EXPLORATORY PROCEDURE WAS PERFORMED IN 2007, AT WHICH TIME IT WAS CONFIRMED THAT A NUCLEAR FRAGMENT HAD EXTRUDED OUT OF THE DISC SPACE. IT WAS ALSO NOTED THAT, THE INCLOSE DEVICE WAS ATTACHED WITH A SINGLE ANCHOR BAND (SUTURE) AND A PORTION WAS ALSO IN THE CANAL. THE NUCLEAR FRAGMENT AND DEVICE WERE REMOVED WITHOUT INCIDENT. DUE TO FIBROTIC ADHESIONS, THE DEVICE WAS DISSECTED AND REMOVED IN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCLOSE SURGICAL MESH SYSTEM SURGICAL MESH, POLYMERIC FTL ANULEX TECHNOLOGIES, INC INCLOSE-RM P060157

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention