BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 835577 · Received April 4, 2007

    Report

    Report Number
    3005501497-2007-00001
    Event Type
    Injury
    Date Received
    April 4, 2007
    Date of Event
    March 6, 2007
    Report Date
    April 4, 2007
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    PMA / PMN Number
    k050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED, AND THEREFORE NO FURTHER EVALUATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE INCLOSE-RM MESH WAS IMPLANTED IN 2007 FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L2-L3. ONE WEEK LATER, THE PATIENT EXPERIENCED ACUTE RECURRENCE OF RADICULAR PAIN. AN EXPLORATORY PROCEDURE WAS PERFORMED IN 2007, AT WHICH TIME IT WAS NOTED AS PER THE PHYSICIAN THAT THE DEVICE HAD EXPULSED WHILE AT LEASE ONE OF THE ANCHOR BANDS WAS INTACT AND THE DEVICE WAS IN CONTINUITY WITH THE ANULUS. DEVICE EXPULSION OCCURRED IN CONJUNCTION WITH A RECURRENT HERNIATION AT L2-L3, LATERAL TO THE IMPLANT SITE. NO MOTOR DEFICIT WAS OBSERVED, AND THERE WAS NO DAMAGE TO THE NERVE ROOT. THE PHYSICIAN REMOVED THE DEVICE WITHOUT INCIDENT. THERE WERE NO ADDITIONAL COMPLICATIONS ASSOCIATED WITH THE PROCEDURE AND THE PHYSICIAN WAS SATISFIED WITH THE RESULT.

    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 P070051

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention