BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCLOSE TISSUE REPAIR SYSTEM

    MDR report key: 2195710 · Received July 20, 2011

    Report

    Report Number
    3005501497-2011-00001
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    GAT
    PMA / PMN Number
    K091432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THIS EVENT INVOLVES A PATIENT WITH A HISTORY OF TWO PREVIOUS DISCECTOMY SURGERIES. FOLLOWING HIS DISCECTOMY SURGERY APPROXIMATELY ONE YEAR AGO, THE XCLOSE TISSUE REPAIR SYSTEM WAS IMPLANTED TO RE-APPROXIMATE THE ANULUS FIBROSUS OF THE INTERVERTEBRAL DISC. THE PATIENT SUBSEQUENTLY APPROACHED A DIFFERENT SURGEON, REPORTING ONGOING LEFT LEG PAIN. (B)(6) RECENTLY PERFORMED FUSION SURGERY TO TREAT THIS PATIENT. PLEASE NOTE THAT THE EVENT DATE REPRESENTS AN ESTIMATE OF THE SURGERY DATE THAT ANULEX WAS UNABLE TO CONFIRM. DURING THE SURGICAL PROCEDURE, (B)(6) NOTED THAT THERE WERE DISC FRAGMENTS IN THE SPINAL CANAL, WHILE ONE ANCHOR OF THE XLCOSE DEVICE WAS FOUND DORSAL TO THE FRAGMENTS AND DIRECTLY IN CONTACT WITH THE NERVE ROOT. THE DEVICE AND FRAGMENTS WERE REMOVED AND THE FUSION PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE PATIENT'S RADICULAR SYMPTOMS WERE IMPROVED AT THE TIME OF FOLLOW-UP TO THE FUSION PROCEDURE. THESE DETAILS WERE OBTAINED IN A PHONE CONVERSATION WITH THE TREATING PHYSICIAN ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCLOSE TISSUE REPAIR SYSTEM SUTURE, NON-ABSORBABLE POLYETHYLENE GAT ANULEX TECHNOLOGIES, INC XC-201-01 102463

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other