BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 774717 · Received October 27, 2006

    Report

    Report Number
    3005501497-2006-00002
    Event Type
    Injury
    Date Received
    October 27, 2006
    Date of Event
    September 13, 2006
    Report Date
    October 27, 2006
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE COMPANY FOR EVALUATION. IT WAS NOTED THAT THE DEVICE WAS DAMAGED DURING REMOVAL AND OFFERED LIMITED INFORMATION FOR THE 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. THE SUTURES (ANCHOR BANDS) WERE RECOVERED AND RETURNED WITH THE MESH, HOWEVER THEY WERE COMPROMISED DURING RETRIEVAL AFFORDING LITTLE OPPORTUNITY TO ASSESS INITIAL PLACEMENT OR OVERALL EFFECTIVENESS. WE CAN ONLY CONCLUDE THAT THE DEVICE FAILED BY A KNOWN FAILURE MODE WHICH IS DEFINED IN THE PACKAGE INSERT AS EXTRUSION.

    Description of Event or Problem · 1

    THE INCLOSE-GSM MESH WAS IMPLANTED IN 2006 FOLLOWING A DISCETOMY PROCEDURE (PARTIAL) FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L4-L5. DISC HEIGHT WAS RECORDED AS 5-6MM AT THE TIME OF IMPLANT. THE MESH WAS IMPANTED THROUGH A HORIZONTAL SLIT IN THE ANULUS AND SECURED WITH ANCHOR BANDS ABOVE AND BELOW THE INCISION LINE. THE PATIENT REPORTED SUDDEN LEG PAIN APPROXIMATELY 6 MONTHS AFTER IMPLANTATION. MRI EVALUATION SUGGESTED DEVICE EXTRUSION AS THE CAUSE OF THE LEG PAIN. AN EXPLORATORY PROCEDURE WAS PERFORMED 7 MONTHS LATER AT WHICH TIME IT WAS NOTED THAT THE DEVICE HAD EXPULSED. THE PHYSICIAN RETRIEVED THE DEVICE AND PERFORMED ADDITIONAL DECOMPRESSION OF THE INTERVERTEBRAL DISC SPACE. DUE TO INGROWTH OF TISSUE, THE DEVICE WAS DAMAGED DURING REMOVAL, COMPROMISING THE OPPORTUNITY FOR SUBSEQUENT INVESTIGATION. IT SEEMS THAT THE MESH WAS INTACT PRIOR TO REMOVAL, BUT THE STATUS OF THE SUTURES (ANCHOR BANDS) REMAINS UNKNOWN. 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-GSM P050471

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention