BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT, UNKNOWN

    MDR report key: 8876186 · Received August 8, 2019

    Report

    Report Number
    1121308-2019-00025
    Event Type
    Injury
    Date Received
    August 8, 2019
    Report Date
    July 15, 2019
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS NOT RETURNED TO INTEGRA AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE ROOT CAUSE IS UNDETERMINED AS THERE IS NOT ENOUGH INFORMATION PROVIDED. 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

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE JOURNAL OF CUTANEOUS MEDICINE AND SURGERY (2019) PUBLISHED: "RECONSTRUCTION OF NASAL DEFECTS WITH DERMAL SKIN SUBSTITUTES-A RETROSPECTIVE STUDY OF 36 DEFECTS". OBJECTIVES: THE AIM OF THIS STUDY WAS TO ASSESS WHETHER THE AESTHETIC SUBUNITS DETERMINE THE OUTCOME. METHODS: IN THIS UNICENTRIC, RETROSPECTIVE STUDY, THE SURGICAL PROCEDURES AND OUTCOMES OF PATIENTS WHO RECEIVED DRTS TO RECONSTRUCT NASAL DEFECTS WERE ASSESSED AND COMPARED WITH THE INVOLVED AESTHETIC SUBUNITS. INTEGRA DUOLAYER AND INTEGRA SINGLE LAYER WAS IMPLANTED, FOLLOWED BY SPLIT-SKIN GRAFTING OR FULL-THICKNESS GRAFTING 3 TO 4 WEEKS LATER. THE INTEGRA DRT WAS APPLIED TO 30 CASES. RESULTS: DRTS WERE USED FOR RECONSTRUCTION OF 36 NASAL DEFECTS IN 35 PATIENTS WITH INVOLVEMENT OF 76 AESTHETIC SUBUNITS: NASAL SIDEWALL (N = 21), NASAL ALA (N = 13), NASAL TIP/COLUMELLA (N = 12, N = 1, RESPECTIVELY), NASAL DORSUM (N = 12), AND EXTRANASAL AESTHETIC AREAS (N = 17). FIFTY-EIGHT NASAL AND 8 EXTRANASAL AESTHETIC SUBUNITS WERE RECONSTRUCTED WITH DRTS, 10 SUBUNITS WITH A FLAP. TWENTY-NINE OF 36 DEFECTS HEALED WITHOUT ANY COMPLICATIONS (80.5%). ALL RECONSTRUCTED NASAL TIPS/COLUMELLA AND THE NASAL DORSA HEALED WITHOUT ANY COMPLICATIONS. REGION-SPECIFIC COMPLICATIONS WERE RETRACTION OF THE ALA RIM (4/12; 33.3% OF THE PATIENTS WITH INVOLVEMENT OF THE NASAL ALA) AND THE FORMATION OF A FISTULA IN THE NASAL SIDEWALL (1/21; 4.8%). REGION-SPECIFIC COMPLICATIONS OF EXTRANASAL SUBUNITS WERE THE DEVELOPMENT OF AN ECTROPIUM (2/3; 66.7% OF THE PATIENTS WITH INVOLVEMENT OF THE LOWER LID). ADVERSE EVENTS: FISTULA - ONE RECONSTRUCTED NASAL SIDEWALL DEVELOPED A FISTULA. CLINICALLY, THE FISTULA SHOWED PERMANENT SECRETION OF NASAL FLUID. THE FISTULA WAS EXCISED AND THE NEW DEFECT RECON­STRUCTED WITH 2 FLAPS (1 TO RECONSTRUCT THE INNER LAYER AND 1 TO RECONSTRUCT THE OUTER LAYER) IN COMBINATION WITH A CARTILAGE GRAFT. ECTROPIUM - TWO OF 3 OF THE NASAL DEFECTS THAT INVOLVED THE LOWER EYE­LIDS DEVELOPED AN ECTROPIUM. ONE ECTROPIUM REQUIRED SURGI­CAL INTERVENTION AFTERWARD. RETRACTION OF THE ALA RIM - FOUR OF 12 RECONSTRUCTED ALAE RIMS SHOWED RETRACTION. AS THE IMPLANTATION OF A DRT REQUIRES THAT SPLIT-SKIN OR FULL-THICKNESS SKIN GRAFTING BE PERFORMED AFTER A TIME, IT IS CURRENTLY NOT POSSIBLE TO STATE WHETHER THE OBSERVED CONTRACTIONS ARE DUE TO THE DRT OR AFTER SKIN GRAFTING. IT IS WELL ESTABLISHED THAT CONTRACTURE OF THE WOUND AFTER SKIN GRAFTING (SPLIT-SKIN AS WELL AS FULL-THICK­NESS SKIN GRAFTING) MAY OCCUR. CONCLUSIONS: DRTS CAN BE HELPFUL TO RECONSTRUCT NASAL DEFECTS. HOWEVER, IF THE DEFECT INVOLVES THE AESTHETIC SUBUNITS NASAL ALA OR THE INFRAORBITAL REGION, DIFFERENT TECHNIQUES SHOULD BE PREFERRED. IN SUMMARY, DRTS ARE EASY TO USE FOR RECONSTRUCTION OF NASAL DEFECTS AFTER TUMOUR EXCISION, EITHER ALONE OR IN COM­BINATION WITH FLAPS. THEY HAVE A LOW COMPLICATION RATE AND SHOW GOOD FUNCTIONAL RESULTS IN CASES OF THE AESTHETIC SUB­UNITS NASAL SIDEWALL, NASAL DORSUM, AND NASAL TIP. DOI: I 0.1 I 77/ I 203475419852060.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668715 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1