BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCLOSE SURGICAL MESH SYSTEM

    MDR report key: 855418 · Received May 22, 2007

    Report

    Report Number
    3005501497-2007-00005
    Event Type
    Injury
    Date Received
    May 22, 2007
    Date of Event
    April 23, 2007
    Report Date
    May 22, 2007
    Manufacturer
    ANULEX TECHNOLOGIES, INC
    Product Code
    FTL
    PMA / PMN Number
    K050969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. SIGNIFICANT TRAUMA RESULTANT OF THE PATIENT'S INVOLVEMENT IN AN ALTERCATION WITH PRISONERS AFTER SIXTEEN WEEKS OF RECOVERY FROM SURGERY MAY HAVE CONTRIBUTED TO A LOSS OF INTEGRITY OF THE SOFT TISSUE 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-RM MESH WAS IMPLANTED IN 2006, FOLLOWING A DISCECTOMY PROCEDURE FOR TREATMENT OF SYMPTOMS RELATED TO A HERNIATED INTERVERTEBRAL DISC AT L5/S1. THE FOLLOWING YEAR, THE PATIENT EXPERIENCED ACUTE RECURRENCE OF LEG PAIN FOLLOWING PHYSICAL TRAUMA SUFFERED DURING HER DUTY AS A PRISON GUARD. AN MRI IDENTIFIED A RUPTURE AT L5/S1. AN EXPLORATORY PROCEDURE WAS PERFORMED IN 2007, AT WHICH TIME THE DEVICE WAS FOUND IN THE SPINAL CANAL, IN CONTINUITY WITH NEURAL STRUCTURES. TWO NUCLEAR (TISSUE) FRAGMENTS WERE FOUND AND REMOVED CEPHALAD AND CAUDAL TO THE DEVICE IN THE CANAL AT L5/S1. THE DEVICE WAS DISSECTED AND REMOVED IN PIECES. THE PATIENT EXHIBITED NO NEURAL DEFICIT UPON WAKING IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCLOSE SURGICAL MESH SYSTEM SURGICAL MESH, POLYMERIC FTL ANULEX TECHNOLOGIES, INC INCLOSE-RM P060311

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention