BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCLOSE TISSUE REPAIR SYSTEM

    MDR report key: 2960834 · Received February 11, 2013

    Report

    Report Number
    3005501497-2012-00001
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    August 13, 2010
    Report Date
    February 8, 2012
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    GAT
    PMA / PMN Number
    K091432
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE XCLOSE TISSUE REPAIR SYSTEM WAS IMPLANTED TO RE-APPROXIMATE THE ANULUS FIBROSUS FOLLOWING DECOMPRESSION OF THE INTERVERTEBRAL DISC. THE PATIENT REPORTED RECURRENCE OF SYMPTOMS IN (B)(6) 2010. IMAGING CONFIRMED BULGING OF THE DISC, BUT DID NOT NOTE EVIDENCE TO SUGGEST A RECURRENCE OR RESIDUAL DISC PROTRUSION. SYMPTOMS WERE MANAGED WITH CONSERVATIVE CARE FOR 6 MONTHS. THE PATIENT WAS SEEN BY A DIFFERENT SURGEON, REPORTING ONGOING LEG PAIN. ON (B)(6) 2010, THE SURGEON PERFORMED MINIMALLY INVASIVE EXPLORATION OF THE LUMBAR LAMINOTOMY. OPERATIVE NOTES INDICATE THAT UPON REACHING THE SITE OF THE ORIGINAL HERNIATION, THE XCLOSE DEVICE WAS VISIBLE AND SEEMED TO BE PROTRUDING, SUCH THAT IT COULD CAUSE PRESSURE ON THE NERVE. THE DEVICE WAS REMOVED AND THE DISC SPACE WAS ENTERED, REMOVING SUPERFICIAL PORTIONS OF THE DISC. ADDITIONAL TISSUE WAS REMOVED TO OBTAIN ADEQUATE DECOMPRESSION OF THE NERVE, AS CONFIRMED BY PASSING A BLUNT NERVE HOOK OUT THE FORAMEN. THE SURGICAL PROCEDURE WAS DONE ON AN OUTPATIENT BASIS WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60014 XCLOSE TISSUE REPAIR SYSTEM SUTURE, NON-ABSORBABLE POLYETHYLENE GAT ANULEX TECHNOLOGIES, INC XC-200-01 101978

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other