BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRT, UNKNOWN

    MDR report key: 24278015 · Received February 6, 2026

    Report

    Report Number
    1121308-2026-00007
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Report Date
    April 17, 2026
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    MDD
    PMA / PMN Number
    P900033
    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: D9, G3, G6, H2, H3, H11. THE IDRT SAMPLE 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. 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

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 1121308-2026-00006. NATIONAL JOURNAL OF MAXILLOFACIAL SURGERY (2025) PUBLISHED: "CAN INTEGRA OUTPERFORM LOCAL FLAPS IN THE RECONSTRUCTION OF FACE AND SCALP SKIN CANCER DEFECTS?" INTRODUCTION: SKIN CANCER OF THE HEAD IS THE COMMONEST CANCER WORLDWIDE, FREQUENTLY AFFECTING OLDER, MEDICALLY COMPLEX PATIENTS, RENDERING POSTRESECTION RECONSTRUCTION CHALLENGING. METHODS: THIS IS A RETROSPECTIVE COHORT STUDY COMPARING THE CLINICAL OUTCOMES OF ONCOLOGIC SOFT TISSUE DEFECT RECONSTRUCTION OF THE HEAD WITH THE INTEGRA DERMAL REGENERATION TEMPLATE VERSUS LOCAL FLAPS. DEFECTS RECONSTRUCTED AT A SINGLE CENTER BETWEEN JANUARY 1, 2022, AND DECEMBER 31, 2022, WERE INCLUDED. MULTIVARIABLE LOGISTIC REGRESSION DETERMINED THE INDEPENDENT EFFECT OF DEMOGRAPHICS AND SURGICAL FACTORS ON THE ODDS OF COMPLICATIONS. RESULTS: A TOTAL OF 125 DEFECTS WERE INCLUDED, 59 RECONSTRUCTED WITH INTEGRA AND 66 WITH A LOCAL FLAP. BASELINE CHARACTERISTICS WERE SIMILAR, BUT PATIENTS WERE SIGNIFICANTLY OLDER WITHIN THE INTEGRA GROUP (84 VS. 78 YEARS, P = 0.022) WITH LARGER DEFECT SIZES (699 MM2 VS. 454 MM2, P < 0.001). MULTIVARIABLE ANALYSIS SHOWED THAT WHEN ACCOUNTING FOR CONFOUNDING VARIABLES, LOCAL FLAP RECONSTRUCTION REMAINS ASSOCIATED WITH SIGNIFICANTLY REDUCED ODDS OF COMPLICATIONS (OR 3.54 [1.59¿8.25], P = 0.002). THE COMMONEST COMPLICATION WAS GRAFT FAILURE, WITH ALL CASES RECORDED IN THE INTEGRA GROUP. GRAFT FAILURE DID NOT CORRELATE WITH CLINICAL FAILURE, AS 90% OF INTEGRA WOUNDS WERE FULLY HEALED AT SIX MONTHS. CONCLUSION: RECONSTRUCTION OF ONCOLOGIC SOFT TISSUE DEFECTS WITH INTEGRA IS RELATED TO HIGH GRAFT FAILURE RATES, LIMITING ITS CLINICAL EFFECTIVENESS COMPARED TO LOCAL FLAPS. SURGICAL FACTORS LIKE SUBSEQUENT EPIDERMAL GRAFTING, FENESTRATION, OR ANTIBIOTIC PROPHYLAXIS ARE LIKELY TO IMPROVE OUTCOMES. THE DEVELOPMENT OF A STANDARDIZED SURGICAL APPROACH BASED ON RANDOMIZED, PROSPECTIVE RESEARCH IS WARRANTED, AS INTEGRA CAN ENABLE THE CLOSURE OF LARGE DEFECTS IN MEDICALLY COMPLEX PATIENTS, UNSUITABLE FOR RECONSTRUCTION BY OTHER METHODS. IN THIS RETROSPECTIVE COHORT STUDY, IDRT (N=59; MEDIAN AGE: 84.0 YEARS) WAS COMPARED TO LOCAL TISSUE FLAPS (N=66; MEDIAN AGE: 78.0 YEARS; P=0.022) FOR THE SOFT RECONSTRUCTION OF HEAD DEFECTS FOLLOWING TUMOR EXCISION. THE WOUND AREA WAS SIGNIFICANTLY LARGER IN THE IDRT GROUP COMPARED TO THE FLAP GROUP (699 MM2 VS. 454 MM2, P<0.001). COMPLETE HEALING ACHIEVED BY 6-MONTH TIME POINT WAS ACHIEVED IN 90% (53/59) OF IDRT-TREATED WOUNDS (VIA SECONDARY INTENTION) AND 100% (66/66) OF LOCAL FLAP-TREATED WOUNDS. THE AUTHORS NOTED THAT THE COSMETIC OUTCOMES FOLLOWING RECONSTRUCTIONS WITH IDRT WERE EXCELLENT, WHICH ALLOWED THE USE OF INTEGRA FOR LARGE WOUNDS LACKING VASCULARIZATION AND ALSO FOR DEFECTS IN COSMETICALLY SENSITIVE AREAS, REDUCING THE RISK OF FACIAL DISTORTION OR NERVE INJURY. THE IDRT GROUP EXHIBITED A SIGNIFICANTLY HIGHER COMPLICATION RATE RELATIVE TO THE FLAP GROUP (57.6% [34/59] VS 30.3% 20/66], RESPECTIVELY; P=0.004). INTEGRA GRAFT FAILURE WAS OBSERVED (47.4% [28/59]). THE INFECTION RATE FOR THE INTEGRA GROUP WAS 18.6% (11/59) COMPARED TO 6.0% (4/66) IN THE FLAP GROUP. THE REOPERATION RATE FOR IDRT WAS 6.4% (8/59) DUE TO PTOSIS CORRECTION, DEHISCENCE, AND POST-RADIATION NONHEALING WOUND, COMPARED TO 7.6% (5/66) IN THE FLAP GROUP, WHICH INCLUDED TWO BROW LIFTS, ONE SCAR REVISION, ONE ALAR RECONSTRUCTION, AND ONE HEMATOMA EVACUATION. THE AUTHORS CONCLUDED THAT RECONSTRUCTION OF ONCOLOGIC SOFT TISSUE DEFECTS WITH IDRT CAN BE ASSOCIATED WITH HIGH GRAFT FAILURE RATES, WHICH MAY LIMIT ITS EFFECTIVENESS COMPARED TO LOCAL FLAPS. HOWEVER, SURGICAL FACTORS LIKE SUBSEQUENT EPIDERMAL GRAFTING, FENESTRATION, OR ANTIBIOTIC PROPHYLAXIS MAY IMPROVE OUTCOMES. NOTE FORM MANUFACTURER - THIS REPORT IS FOR MALFUNCTION: GRAFT FAILURE. DOI:10.4103/NJMS.NJMS_16_25.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96485 IDRT, UNKNOWN WOUND RECON - ACUTE MDD INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown