BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT, UNKNOWN

    MDR report key: 15001809 · Received July 13, 2022

    Report

    Report Number
    1121308-2022-00070
    Event Type
    Injury
    Date Received
    July 13, 2022
    Report Date
    September 15, 2022
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE XXX-IDRT WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, THE MOST PROBABLE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO THE UNDERLYING HEALTH CONDITIONS (SPECIFICALLY, THE PRESENCE OF FOURTH-DEGREE BURNS THAT RENDER PATIENTS SUSCEPTIBLE TO INFECTIONS) OF THOSE WITHIN THE STUDY. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    THE JOURNAL OF BURN CARE AND RESEARCH (2007) PUBLISHED: "SEVEN YEARS¿ EXPERIENCE WITH INTEGRA AS A RECONSTRUCTIVE TOOL" THE BILAYERED DERMAL SUBSTITUTE INTEGRA (INTEGRA LIFE SCIENCES CORP., (B)(4)) WAS DEVELOPED AND HAS BEEN WIDELY USED AS PRIMARY COVERAGE FOR EXCISED ACUTE BURNS. OUR TAKE HAS BEEN SLIGHTLY DIFFERENT, FINDING IT MOST USEFUL IN THE MANAGEMENT OF COMPLEX SOFT-TISSUE LOSS AND THREATENED EXTREMITIES AS THE RESULT OF TENDON, JOINT, OR BONE EXPOSURE. OFTEN TASKED TO FILL SIGNIFICANT VOLUME LOSS, WE HAVE BECOME ADEPT AT STACKED MULTIPLE-LAYER APPLICATIONS. CREATIVE USE OF THIS MATERIAL HAS RESULTED IN UNEXPECTED SUCCESSES WITH DISTAL LIMB SALVAGE; THE TECHNIQUE TAKES ITS PLACE BESIDE ADJACENT TISSUE TRANSFER, COMPOSITE FLAPS, AND VASCULAR PEDICLE FLAPS IN OUR BURN RECONSTRUCTIVE PRACTICE. A PROSPECTIVE REGISTRY ( 44 PATIENTS) HAS BEEN KEPT DURING THE PAST 7 YEARS THAT CATALOGS WOUNDS WITH COMPLEX SOFT-TISSUE LOSS TREATED WITH INTEGRA GRAFTS. MANY OF THESE PATIENTS WERE AT RISK OF EXTREMITY LOSS BECAUSE OF EXPOSED TENDONS, JOINTS, OR BONE. INTEGRA WAS APPLIED AFTER 1:1 MESHING. WITH PROFOUND SOFT-TISSUE DEFECTS, MULTIPLE LAYERS OF LNTEGRA WERE SERIALLY APPLIED 1 TO 2 WEEKS APART FOR RECONSTITUTION OF SOFT-TISSUE CONTOURS. LOCAL INTEGRA GRAFT INFECTIONS WERE MANAGED BY SILICONE UNROOFING FOLLOWED BY TOPICAL SULFAMYLON LIQUID DRESSINGS. WOUNDS ADDRESSED INCLUDED FOURTH-DEGREE BURNS, NECROTIZING FASCIITIS, PIT-VIPER EN-VENOMATIONS, AND TOTAL ABDOMINAL WALL AVULSION IN ONE PATIENT AFTER BEING RUN OVER BY A BUS. PATIENTS GENERALLY WERE FREE OF PAIN FROM THEIR WOUNDS DURING THE MATURATION PHASE OF THE INTEGRA NEODERMIS. RESTORATION OF TISSUE CONTOUR WAS SIGNIFICANTLY BETTER WHEN USING MULTIPLE LAY­ ERS FOR DEEP DEFECTS. SECOND AND THIRD LAYERS OF INTEGRA WERE SUCCESSFULLY APPLIED AFTER AN ABBREVIATED FIRST GRAFT MATURATION PERIOD OF 7 DAYS. EPITHELIAL AUTOGRAFTS ON MULTILAYER INTEGRA APPLICATIONS FREQUENTLY "GHOSTED"; THEY WOULD AUTO-DIGEST TO DISPERSED CELLS FOLLOWED SUBSEQUENTLY BY THE REAPPEARANCE OF A CONFLUENT EPITHELIAL LAYER. FINAL GRAFTED SKIN MORPHOLOGY OVER PALMAR AND PLANTAR SURFACES ASSUMED THE TYPE AND FINGERPRINT PATTERN OF THE ORIGINAL TISSUES. IN­FECTIONS WERE READILY VISIBLE. EARLY RECOGNITION KEPT THEM TO EASILY TREATED CIRCUMSCRIBED AREAS, WHICH DID NOT JEOPARDIZE THE ENTIRE WOUND. LENGTHS OF STAY WERE LONG (RANGE, 2-246 DAYS) BUT NOT SIGNIFICANTLY GREATER THAN WITH TRADITIONAL TECHNIQUES. THE SPECIFIC RECONSTRUCTIVE USE OF LNTEGRA PERMITTED UNEXPECTED SALVAGE OF SEVERAL THREATENED EXTREMITIES BY PROTECTING EXPOSED TEN­DONS, BONES AND JOINTS. LONG-TERM HISTOLOGIC EXAMINATION REVEALED UNEXPECTED PERSISTENCE OF LNTEGRA COLLAGEN. LARGE VOLUME LOSS WOUNDS BENEFITED FROM THE ABILITY TO FILL VOIDS WITH MULTI­LAYERED APPLICATIONS. OF THESE, 16 PATIENTS IN THE CONTROL GROUP AND 35 IN THE INTEGRA CASE GROUP WERE DEEMED AT RISK FOR EXTREMITY LOSS BASED ON FOURTH DEGREE BURNS OF AT LEAST ONE EXTREMITY. THE OTHER PATIENTS HAD FOURTH-DEGREE BURNS INVOLVING THE SCALP, FACE, OR TORSO. THIS REPORT IS FOR ADVERSE EVENT TO INCLUDE - LOCAL INTEGRA GRAFT INFECTIONS, TYPICALLY LESS THAN 10 MM IN DIAMETER, APPEARED AS SUBSILICONE PURULENT COLLECTIONS DURING THE 14-DAY NEODERMIS MATURATION PERIOD. THESE WERE MANAGED BY STERILE PREPARATION OF THE SITES FOLLOWED BY UNROOFING WITH IRIS SCISSORS. THESE WOUNDS WERE THEN SELECTIVELY TREATED WITH TOPICAL SULFAMYLON LIQUID OR ACTICOAT ANTIMICROBIAL DRESSINGS. DOI: 10.1097/BCR.0B013E31802CB83F.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702790 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown