BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 800100 · Received December 21, 2006

    Report

    Report Number
    3005501497-2006-00003
    Event Type
    Injury
    Date Received
    December 21, 2006
    Date of Event
    November 28, 2006
    Report Date
    December 20, 2006
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE COMPANY FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED DEVICE DEMONSTRATED THAT IT DEPLOYED INTO A SHAPE CONSISTENT WITH WHAT WOULD BE EXPECTED FOR THE ANATOMICAL SPACE TO WHICH IT WAS APPLIED. SIGNIFICANT FORCES RESULTANT OF THE PATIENT FALLING DOWN STAIRS AFTER SIX WEEKS OF RECOVERY FROM SURGERY MAY HAVE CONTRIBUTED TO A LOSS OF INTEGRITY OF THE ANULUS AND SUBSEQUENT DEVICE EXPULSION. WE CAN ONLY CONCLUDE THAT THE DEVICE FAILED BY A KNOWN FAILURE MODE, DEFINED IN THE PACKAGE INSERT AS EXTRUSION.

    Description of Event or Problem · 1

    THE INCLOSE-GSM MESH WAS IMPLANTED IN 2006 FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L5-S1. THE PATIENT EXPERIENCED A FALL ON SOME STAIRS APPROXIMATELY 6 WEEKS AFTER IMPLANTATION AND REPORTED SCIATICA IMMEDIATELY FOLLOWING THE FALL. MRI EVALUATION CONFIRMED NERVE ROOT COMPRESSION. AN EXPLORATORY PROCEDURE WAS PERFORMED AT WHICH TIME IT WAS NOTED AS PER THE PHYSICIAN THAT THE DEVICE HAS EXPULSED WHILE THE ANCHOR BANDS WERE INTACT AND THE DEVICE WAS IN CONTINUITY WITH THE ANULUS. DEVICE EXPULSION OCCURRED IN CONJUNCTION WITH A LOSS OF INTEGRITY OF THE ANULUS. NO MOTOR DEFICIT WAS OBSERVED AND THERE WAS NO DAMAGE TO THE NERVE ROOT. THE PHYSICIAN REMOVED THE DEVICE AND CONFIRMED THAT THE INTERVERTEBRAL DISC SPACE WAS EMPTY. 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 INC-CLIN P060180

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention