BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDRT, UNKNOWN

    MDR report key: 21364213 · Received February 12, 2025

    Report

    Report Number
    1121308-2025-00004
    Event Type
    Injury
    Date Received
    February 12, 2025
    Report Date
    April 28, 2025
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10. THE 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 MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER, THE MOST PROBABLE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO THE UNDERLYING HEALTH CONDITIONS OF THE PATIENT 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

    THIS IS 1 OF 3 REPORTS LINKED TO MFG REPORT NUMBER: 3005920706-2025-00002. 3005920706-2025-00003. THE EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY (2024) PUBLISHED "URINARY BLADDER MATRIX VERSUS DERMAL REGENERATION TEMPLATE FOR LOWER EXTREMITY WOUND COVERAGE." THE PURPOSE OF THIS STUDY IS TO COMPARE DERMAL REGENERATIVE TEMPLATE (DRT), WITH AND WITHOUT SPLIT-THICKNESS SKIN-GRAFTING (STSG), AND URINARY BLADDER MATRIX (UBM) FOR COVERAGE OF LOWER EXTREMITY WOUNDS. METHODS: A RETROSPECTIVE REVIEW OF 56 LOWER EXTREMITY WOUNDS TREATED WITH EITHER DRT AND STSG (DRT-S) (N =18), DRT ONLY (N=17), OR UBM ONLY (N=21). PATIENT CHARACTERISTICS, COMORBIDITIES, AMERICAN SOCIETY OF ANESTHESIOLOGY (ASA) CLASSIFICATION, INJURY CHARACTERISTICS, WOUND CHARACTERISTICS, USE OF NEGATIVE PRESSURE WOUND THERAPY, SURGICAL DETAILS, POSTOPERATIVE CARE, AND FAILURE OF PRIMARY WOUND COVERAGE PROCEDURE WERE DOCUMENTED. RESULTS: THE DRT GROUP, COMPARED TO THE DRT-S GROUP, WAS OLDER (MEDIAN DIFFERENCE (MD) 17.4 YEARS, 95% CONFIDENCE INTERVAL (CI) 9.1-25.7; P=0.0008), MORE DIABETIC (PROPORTIONAL DIFFERENCE (PD) 54.2%, CI 21.2-76.1%; P=0.002), HAD SMALLER WOUNDS (MD -91.0 CM2, CI -125.0 TO -38.0; P=0.0008), MORE INFECTED WOUNDS (PD 49.0%, CI 16.1-71.7%; P=0.009), A SHORTER LENGTH OF STAY AFTER COVERAGE (MD -5.0 DAYS, CI -29.0 TO -1.0; P=0.005), AND NO DIFFERENCE IN PRIMARY WOUND COVERAGE FAILURE (41.2% VS. 55.6%; P=0.50). THE UBM GROUP, COMPARED TO THE DRT GROUP, WAS YOUNGER (MD -6.8 YEARS; CI -13.5 TO -0.1; P=0.04), HAD FEWER PATIENTS WITH AN ASA HIGHER THAN 2 (PD -35.0%, CI -55.2% TO -7.0%; P=0.02), DIABETES (PD -49.2%, CI -72.4% TO -17.6%; P=0.003), AND HAD NO DIFFERENCE IN PRIMARY WOUND COVERAGE FAILURE (36.4% VS. 41.2%; P=1.0). FAILURE OF PRIMARY WOUND COVERAGE WAS FOUND TO ONLY BE ASSOCIATED WITH LARGER WOUND SURFACE AREAS (MD 22.0 CM2, CI 4.0-90.0; P=0.01). CONCLUSIONS: DRT AND UBM COVERAGE HAD SIMILAR RATES OF PRIMARY WOUND COVERAGE FAILURE FOR LOWER EXTREMITY WOUNDS. THIS REPORT IS FOR: ADVERSE EVENT/MALFUNCTION IDRT (INTEGRA DERMAL REGENERATIVE TEMPLATE): FAILED PRIMARY WOUND COVERAGE WITH THE ASSOCIATED HARMS OF INFECTION AND REVISION SURGERY. HTTPS://DOI.ORG/10.1007/S00590-024-03888-9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895767 IDRT, UNKNOWN INTEGRA MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention