BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 940596 · Received November 8, 2007

    Report

    Report Number
    3005501497-2007-00013
    Event Type
    Injury
    Date Received
    November 8, 2007
    Date of Event
    October 10, 2007
    Report Date
    November 8, 2007
    Manufacturer
    ANULEX TECHNOLOGIES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 IMPLANTED IN 2006 FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L4/L5. AT THE TIME OF THE ORIGINAL SURGERY, THE PATIENT HAD AN L5/S1 HERNIATION ON THE LEFT, BUT IT WAS NOT CAUSING PAIN AND WAS NOT TREATED. THE PATIENT WORKS IN LAW ENFORCEMENT AND EXPERIENCED RECURRING SYMPTOMS AFTER "GRAPPLING" IN A TRAINING EXERCISE. MRI IN 2007 IDENTIFIED RECURRENCE AT L4-L5 AND HERNIATION AT L5-S1. SYMPTOMS AT THE TIME OF RECURRENCE INCLUDED 10% LOWER BACK PAIN, 90% LEG PAIN (RIGHT) EXTENDING TO THE FOOT WITH NUMBNESS AND WEAKNESS IN THE RIGHT LEG AND FOOT. INTRAOPERATIVE OBSERVATION CONFIRMED THE MESH TO BE INTACT AND IT WAS REMOVED IN TWO PIECES. THE DEVICE WAS NOT RETURNED FOR EVALUATION. AFTER REMOVING THE MESH, THE L4-L5 DISC SPACE WAS PREPARED FOR INTERBODY FUSION. IN ADDITION, POSTEROLATERAL FUSION WITH PEDICLE SCREWS WAS PERFORMED FROM L4 TO S1. THERE WERE NO COMPLICATIONS AND 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 P050543

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention