BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 1231851 · Received November 12, 2008

    Report

    Report Number
    3005501497-2008-00002
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ANULEX TECHNOLOGIES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 2006 FOLLOWING A DISCECTOMY PROCEDURE, FOR TREATMENT OF SYMPTOMS RELATED TO A RE-HERNIATED INTERVERTEBRAL DISC AT L4/L5. THE SURGEON HAD PREVIOUSLY PERFORMED A PERCUTANEOUS DISCECTOMY ON THE SAME LEVEL AND SIDE ABOUT ONE MONTH PRIOR. THE PATIENT APPROACHED A NEW SURGEON IN 2008 REPORTING PERSISTENT PAIN. MR IMAGES INDICATED A PROTRUSION AT L4/L5. EXPLORATORY SURGERY PERFORMED AT ABOUT A MONTH LATER REVEALED THAT THE DEVICE WAS OUTSIDE THE ANULUS FIBROSUS. SCAR TISSUE HAD ENCAPSULATED THE MESH AND AFTER CAREFUL REMOVAL, THE SURGEON IDENTIFIED A DURAL TEAR THAT REQUIRED REPAIR. AFTER REPAIR OF THE DURAL TEAR, THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION.

    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 P060280

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention