BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND MATRIX - UNSPECIFIED

    MDR report key: 22977785 · Received September 5, 2025

    Report

    Report Number
    3004170064-2025-00003
    Event Type
    Injury
    Date Received
    September 5, 2025
    Report Date
    October 14, 2025
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    FTM
    PMA / PMN Number
    K071807
    Removal / Correction Number
    3004170064-05/23/2023-00
    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 HEALTH EFFECT - CLINICAL CODE: - E2327. - E172002.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - D8, D9, G6, H1, H2, H3, H6, H11. THE SURGIMEND MATRIX 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

    PUBLIC AND RECONSTRUCTIVE SURGERY (2022) PUBLISHED. " UTILITY OF DERMAL WOUND MATRICES COMPARED WITH LOCAL-TISSUE REARRANGEMENT AND FREE FLAP RECONSTRUCTION FOR ONCOLOGIC SCALP WOUNDS: A MULTIDISCIPLINARY DUAL MATCHED-PAIR ANALYSIS. BACKGROUND: "ACELLULAR DERMAL MATRICES (ADMS) ARE FREQUENTLY EMPLOYED IN IMMEDIATE PROSTHESIS-BASED BREAST RECONSTRUCTION (IPBR) TO PROVIDE STRUCTURAL SUPPORT. DESPITE DIFFERENCES IN ADM DERIVATIVES, FEW STUDIES DIRECTLY COMPARE THEIR OUTCOMES IN THE SETTING OF IPBR. WE SOUGHT TO CONDUCT A LARGE HEAD-TO-HEAD STUDY COMPARING 3 ADMS USED ACROSS OUR INSTITUTION." METHODS: "A MULTICENTER RETROSPECTIVE REVIEW OF PATIENTS UNDERGOING IPBR WITH SURGIMEND PRS (FETAL BOVINE¿DERIVED; INTEGRA LIFESCIENCES, PRINCETON, NJ), ALLODERM (HUMAN-DERIVED; LIFECELL CORP, BRIDGEWATER, NJ), OR DERMACELL (HUMAN-DERIVED; STRYKER CORP, KALAMAZOO, MI) BETWEEN JANUARY 2014 TO JULY 2022 WAS PERFORMED. PRIMARY OUTCOMES INCLUDED RATES OF UNPLANNED EXPLANTATION AND TOTAL RECONSTRUCTIVE FAILURE. SECONDARY OUTCOMES INCLUDED 90-DAY POSTOPERATIVE COMPLICATIONS AND LONG-TERM RATES OF CAPSULAR CONTRACTURE DEVELOPMENT." RESULTS: "A TOTAL OF 738 PATIENTS (1228 BREASTS) UNDERWENT IPBR DURING THE STUDY PERIOD; 405 PATIENTS RECEIVED DERMACELL (54.9%), 231 RECEIVED ALLODERM (31.3%), AND 102 RECEIVED SURGIMEND PRS (13.8%). RATES OF SHORT-TERM COMPLICATIONS, TOTAL RECONSTRUCTION FAILURE, REOPERATION WITHIN 90 DAYS, CAPSULAR CONTRACTURE, AND UNPLANNED EXPLANTATION WERE COMPARABLE. THESE FINDINGS REMAINED TRUE UPON MULTIVARIATE ANALYSIS ACCOUNTING FOR BASELINE DIFFERENCES BETWEEN COHORTS, WHEREBY ADM TYPE WAS NOT AN INDEPENDENT PREDICTOR OF ANY OUTCOME OF INTEREST. CONVERSELY, FACTORS SUCH AS BODY MASS INDEX, DIABETES MELLITUS, SMOKING HISTORY, NEOADJUVANT AND ADJUVANT CHEMOTHERAPY, ADJUVANT RADIATION, SKIN-SPARING MASTECTOMY, WISE PATTERN AND PERIAREOLAR INCISIONS, USE OF TISSUE EXPANDERS, AND A SUBPECTORAL PLANE OF INSERTION WERE SIGNIFICANT PREDICTORS OF POSTOPERATIVE COMPLICATED. CONCLUSION: LOW RATES OF COMPLICATIONS SUPPORT THE EQUIVALENCY OF FETAL BOVINE AND HUMAN-DERIVED ADMS IN IPBR. PATIENT CHARACTERISTICS AND OPERATIVE APPROACH ARE LIKELY MORE PREDICTIVE OF POSTOPERATIVE OUTCOMES THAN ADM DERIVATIVE ALONE. NOTE FROM MANUFACTURER (INTEGRA): THIS REPORT IS FOR ADVERSE EVENTS: - SEROMA, 8.5% (14). - HEMATOMA, 2.4% (4). - DEHISCENCE, 4.2% (7). - DELAYED WOUND HEALING, 2.4% (4). - MASTECTOMY FLAP NECROSIS, 4.8% (8). - RED BREAST SYNDROME, 0.0% (0). - CELLULITIS, 3.6% (6) SSI, 3.6% (6). - TOTAL RECONSTRUCTIVE FAILURE, 5.5% (9). - CAPSULAR CONTRACTURE, 6.1% (10). - UNPLANNED EXPLANTATION, 10.3% (17). DOI: 10.1097/SAP.0000000000003990.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266299 SURGIMEND MATRIX - UNSPECIFIED N/A FTM TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other