BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 843015 · Received April 27, 2007

    Report

    Report Number
    3005501497-2007-00003
    Event Type
    Injury
    Date Received
    April 27, 2007
    Date of Event
    March 29, 2007
    Report Date
    April 27, 2007
    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 AND CONSEQUENTLY NO FURTHER EVAL COULD BE PERFORMED.

    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 L3/L4. FOUR MONTHS LATER, THE PT EXPERIENCED ACUTE RECURRENCE OF RADICULAR PAIN FOLLOWING A PHYSICAL THERAPY SESSION INCORPORATING A NEW EXERCISE. MRI PERFORMED ON 3/7/07 REVEALED WHAT APPEARED TO BE A RECURRENT HERNIATION. AN EXPLORATORY PROCEDURE WAS PERFORMED THREE WEEKS LATER, AT WHICH TIME IT WAS NOTED AS PER THE PHYSICIAN, THAT THE DEVICE HAD EXPULSED. BOTH ANCHOR BANDS REMAINED INTACT AND AFFIXED TO THE MESH, WHICH APPEARED TO BE PROPERLY DEPLOYED AND LATCHED. NO MOTOR DEFICIT WAS OBSERVED AND THERE WAS NO DAMAGE TO THE NERVE ROOT. THE PHYSICIAN REMOVED THE DEVICE WITHOUT INCIDENT. THERE WERE NO ADD'L 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 P060204

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention