BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCLOSE TISSUE REPAIR SYSTEM

    MDR report key: 1270527 · Received December 16, 2008

    Report

    Report Number
    3005501497-2008-00003
    Event Type
    Injury
    Date Received
    December 16, 2008
    Date of Event
    November 17, 2008
    Report Date
    December 16, 2008
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    GAT
    PMA / PMN Number
    K062307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THIS INCIDENT OCCURRED WHILE THE XCLOSE DELIVERY INSTRUMENT WAS BEING REMOVED FROM THE SURGICAL FIELD. TENSION BANDS WERE BEING PLACED IN THE SOFT-TISSUE DEFECT OF THE ANULUS FIBROSUS AT L5/S1. AS THE XCLOSE DELIVERY INSTRUMENT WAS BEING REMOVED, THE TISSUE STOP ON THE XCLOSE DELIVERY TOOL CONTACTED THE DURA AND CAUSED A DURAL TEAR. THE SURGEON SUTURED THE DURA AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCLOSE TISSUE REPAIR SYSTEM NON-ABSORBABLE PET SURGICAL SUTURE GAT ANULEX TECHNOLOGIES, INC XCLOSE-TRS 101534

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention