BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR MOSAIC

    MDR report key: 6383325 · Received March 7, 2017

    Report

    Report Number
    3011175548-2017-00008
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    January 6, 2017
    Report Date
    March 7, 2017
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    UDI-DI
    00650862311068
    PMA / PMN Number
    K121070
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ON THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF ALL LOT HISTORY AND STERILIZATION RECORDS WAS CONDUCTED. ALL IN-PROCESS SPECIFICATIONS AND RELEASE CRITERIA WERE MET, INCLUDING PRE-AND-POST-STERILE SEAL STRENGTH TESTING ON THE PACKAGING AND FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) AND COATING DENSITY TESTING ON THE CURED COATED PANEL. BALL BURST, SUTURE RETENTION (COURSE AND WALE DIRECTIONS), AND FTIR TESTING WAS CONDUCTED ON THE POLYPROPYLENE MESH MATERIAL AT INCOMING AND ALL ACCEPTANCE CRITERIA WAS ALSO MET. CLINICAL EVALUATION: THE C-QUR MOSAIC MESH IS INTENDED FOR USE IN SOFT TISSUE DEFICIENCIES INCLUDING HERNIA REPAIR, CHEST WALL RECONSTRUCTION, TRAUMATIC OR SURGICAL WOUNDS AND OTHER FASCIAL SURGICAL INTERVENTIONAL PROCEDURES REQUIRING REINFORCEMENT WITH A SUPPORTIVE MATERIAL. COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY SURGICAL MESH INCLUDE, BUT ARE NOT LIMITED TO INFLAMMATION, PAIN AND MECHANICAL DISRUPTION OF TISSUE. THE INSTRUCTIONS FOR USE (IFU) STATES ADEQUATE MESH FIXATION IS REQUIRED TO MINIMIZE POST-OPERATIVE COMPLICATIONS. A PRODUCT MAY TEAR DURING SUTURING IF IT IS INCORRECTLY SIZED FOR THE PLANNED INTERVENTION, IF EXCESSIVE TENSION EXISTS BETWEEN THE MESH MATERIAL AND THE TISSUE AND IF THE SUTURE/STAPLES/TACKERS ARE NOT PLACED ADEQUATELY. THE MESH PRODUCT SHOULD BE SHAPED, SIZED AND ANCHORED TAKING INTO CONSIDERATION THE PATIENT'S POSTURE, WEIGHT AND ANATOMICAL LOCATION. IN ORDER TO MINIMIZE TENSION AT THE SUTURE LINE, THE MESH SHOULD BE SIZED AND POSITIONED SO THAT IT EXTENDS ADEQUATELY BEYOND THE MARGINS OF THE DEFECT. THE INSTRUCTIONS FOR USE (IFU) ADVISE THAT CAREFUL ATTENTION TO SUTURE/STAPLE/TACKER PLACEMENT AND SPACING WILL HELP TO PREVENT EXCESSIVE TENSION OR DISRUPTION OF THE MESH MATERIAL OR UNDERLYING TISSUE. THE IFU STATES ADEQUATE MESH FIXATION IS REQUIRED TO MINIMIZE POST-OPERATIVE COMPLICATIONS. THE FIXATION TECHNIQUE, METHOD, AND PRODUCTS USED ARE LEFT TO THE DISCRETION OF THE SURGEON TO OPTIMIZE CLINICAL OUTCOMES.

    Description of Event or Problem · 1

    WHEN SURGEON TRIED TO PASS A SUTURE THROUGH THE MIDDLE OF THE PRODUCT, THE PRODUCT HAD A HOLE TORN IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166382 C-QUR MOSAIC MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORP. 31106 407066 00650862311068

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR