BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 1365116 · Received April 17, 2009

    Report

    Report Number
    3005501497-2009-00001
    Event Type
    Injury
    Date Received
    April 17, 2009
    Date of Event
    July 12, 2007
    Report Date
    April 17, 2009
    Manufacturer
    ANULEX TECHNOLOGIES, INC.
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 2007 FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L3-L4. THE PT RETURNED TO THE CLINIC THREE MONTHS LATER WITH RECURRENT RIGHT L4 RADICULOPATHY. EXPLORATORY SURGERY WAS PERFORMED FOUR MONTHS LATER. AFTER LYSIS OF ADHESIONS AND REMOVAL OF RECURRENT DISC EXTRUSION, THE MESH WAS FOUND WITHIN THE DISC SPACE, BUT DID NOT APPEAR TO BE SECURED TO THE ANULUS ON THE LATERAL SIDE OF THE REPAIR SITE. THE MESH WAS REMOVED AND AGGRESSIVE DISCECTOMY WAS PERFORMED UNTIL THE DISC SPACE WAS LARGELY EMPTIED. THE PT WAS LAST SEEN FOR FOLLOW UP SIX MONTHS LATER, AND REPORTED SIGNIFICANT RELIEF OF SOME ASSOCIATED LEFT LOWER EXTREMITY PAIN WHILE EXPERIENCING PERSISTENT RIGHT LOWER EXTREMITY PAIN THAT CAN ONLY BE ATTRIBUTED TO EPIDURAL SCAR TISSUE. NO FURTHER NEUROSURGICAL F/U WAS REQUIRED.

    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 P060477

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention