BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR MOSAIC MESH

    MDR report key: 7542087 · Received May 24, 2018

    Report

    Report Number
    3011175548-2018-00522
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 24, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K121070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED AS PART OF THE COMPLAINT AS IT WAS SUCCESSFULLY IMPLANTED. NO IMAGES OF THE SORBAFIX TACKS WERE PROVIDED SHOWING THAT THEY HAD GONE THROUGH THE MESH. A FULL REVIEW OF ALL MANUFACTURING LOT HISTORY RECORDS WAS PERFORMED AND NO DEFICIENCIES WERE NOTED DURING THE REVIEW. ALL PRODUCT MANUFACTURED MET THE PRODUCT REQUIREMENTS. BASED ON THE PRODUCT MEETING ALL PRODUCT QUALITY AND PERFORMANCE REQUIREMENTS ATRIUM CANNOT CONCLUDE THAT THE C-QUR MOSAIC MESH WAS DEFECTIVE. CLINICAL EVALUATION: A VENTRAL HERNIA IS A BULGE THROUGH AN OPENING IN THE MUSCLES OF THE MIDDLE OF THE ABDOMEN. THE HERNIA CAN OCCUR AT A PAST INCISION SITE (INCISIONAL), ABOVE THE NAVEL (EPIGASTRIC), OR OTHER WEAK MUSCLE SITES (PRIMARY ABDOMINAL). C-QUR MOSAIC IS INTENDED FOR USE IN SOFT TISSUE DEFICIENCIES INCLUDING HERNIA REPAIR, TRAUMATIC OR SURGICAL WOUNDS AND CHEST WALL RECONSTRUCTION PROCEDURES REQUIRING REINFORCEMENT WITH A NON-ABSORBABLE SUPPORTIVE MATERIAL. ADEQUATE MESH FIXATION IS REQUIRED TO MINIMIZE POST-OPERATIVE COMPLICATIONS AND RECURRENCE. THE FIXATION TECHNIQUE, METHOD, AND PRODUCTS USED (INCLUDING SUTURES, TACKS, STAPLES OR OTHER MEANS) IS LEFT TO THE DISCRETION OF THE SURGEON TO OPTIMIZE CLINICAL OUTCOMES. CAREFUL ATTENTION TO SUTURE/STAPLE/TACKER PLACEMENT AND SPACING WILL HELP PREVENT EXCESSIVE TENSION OR DISRUPTION OF THE MESH MATERIAL AND/OR UNDERLYING TISSUE. IT IS RECOMMENDED THAT SUTURE/STAPLES/TACKERS BE PLACED A MINIMUM OF 5 MM FROM THE EDGE OF THE MESH FOR BEST RESULTS. THE INSTRUCTIONS FOR USE (IFU) STATES COMPLICATIONS THAT MAY OCCUR WITH THE USE OF ANY SURGICAL MESH INCLUDE, BUT ARE NOT LIMITED TO, PAIN, INFLAMMATION, INFECTION, ALLERGIC REACTION, SEROMA, HEMATOMA, FISTULA FORMATION OR MECHANICAL DISRUPTION OF THE TISSUE AND/OR MESH MATERIAL AND POSSIBLY ADHESIONS WHEN PLACED IN DIRECT CONTACT WITH THE VISCERA AND OTHER ORGANS. THE PATIENT SHOULD BE ADVISED TO CONTACT THE PHYSICIAN SHOULD AN ADVERSE REACTION OCCUR.

    Description of Event or Problem · 1

    SURGEON USED C-QUR MOSAIC MESH FOR A LAP VENTRAL HERNIA. A FEW OF THE SORBAFIX TACKS WENT THROUGH THE ENTIRE MESH FAILING TO FIXATE TO THE TISSUE. THE MESH WAS LEFT IN THE PATIENT, AS MOST OF THE TACKS WERE FIXATED PROPERLY, 45 IN TOTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384068 C-QUR MOSAIC MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL 31107 424777

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention