BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIMEND MATRIX - UNSPECIFIED

    MDR report key: 22977787 · Received September 5, 2025

    Report

    Report Number
    3004170064-2025-00004
    Event Type
    Injury
    Date Received
    September 5, 2025
    Report Date
    October 14, 2025
    Manufacturer
    TEI BIOSCIENCES INC
    Product Code
    OXH
    PMA / PMN Number
    K083898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, 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.

    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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    JOURNAL OF BRITISH ASSOCIATION OF PLASTIC, RECONSTRUCTIVE AND AESTHETIC SURGEONS (2023) PUBLISHED: "PREOPERATIVE CT IMAGING AS A TOOL TO PREDICT INCISIONAL HERNIA OUTCOMES FOLLOWING ABDOMINAL WALL RECONSTRUCTION: A RETROSPECTIVE COHORT ANALYSIS." SUMMARY: INTRODUCTION: VENTRAL WALL HERNIA OFTEN CAUSES SIGNIFICANT MORBIDITY AND REQUIRES COMPLEX ABDOMINAL WALL RECONSTRUCTION (AWR). THIS STUDY AIMS TO DETERMINE WHETHER SUBCUTANEOUS ABDOMINAL FAT THICKNESS (AFT) MEASURED WITH PREOPERATIVE CT SCANS COULD PREDICT POSTOPERATIVE OUTCOMES IN PATIENTS UNDERGOING AWR. METHODS: A RETROSPECTIVE COHORT STUDY WAS CONDUCTED ON ALL PATIENTS WHO UNDERWENT AWR AT OUR INSTITUTION BETWEEN 2009 AND 2021, WITH A MINIMUM FOLLOW-UP OF 12 MONTHS. USING PREOPERATIVE CT SCANS, AFT WAS MEASURED AT THE XIPHOID PROCESS, UMBILICUS, AND PUBIC TUBERCLE, AS WELL AS THE HERNIA DIMENSIONS. DEMOGRAPHIC, OPERATIVE, AND SURGICAL OUTCOME DATA WERE ALSO COLLECTED AND ANALYZED USING STATISTICAL TESTS. RESULTS: THE RESULTS SHOWED THAT 9 OF 101 PATIENTS (8.9%) EXPERIENCED HERNIA RECURRENCE. SMOKING WAS ASSOCIATED WITH AN INCREASED RISK OF HERNIA RECURRENCE (P < 0.001) WITH A PREDICTIVE ODDS RATIO (OR) OF 18.27 (P = 0.041). INCREASED AFT AT THE XIPHOID (P = 0.005), UMBILICUS (P < 0.001), AND PUBIC TUBERCLE (P < 0.001) WERE ALSO ASSOCIATED WITH HERNIA RECURRENCE AND RISK OF INFECTION. ONLY AFT AT THE PUBIC TUBERCLE REACHED SIGNIFICANCE IN THE REGRESSION MODEL PREDICTING RECURRENCE (OR=1.10; P = 0.030) AND INFECTION (OR=1.04; P = 0.021). A CUT-OFF VALUE OF 67 MM WAS ASSOCIATED WITH A POSITIVE PREDICTIVE VALUE OF 42.14% (SENSITIVITY OF 67% AND SPECIFICITY OF 91%). HERNIA DEFECT AREA WAS NOT ASSOCIATED WITH RISK OF RECURRENCE OR INFECTION. CONCLUSIONS SMOKING AND INCREASED AFT AT THE PUBIC TUBERCLE ARE SIGNIFICANT PREDICTIVE FACTORS FOR RECURRENCE AND INFECTION IN PATIENTS UNDERGOING AWR, AND PREOPERATIVE OPTIMIZATION SHOULD FOCUS ON REDUCING THESE FACTORS. NOTE FROM MANUFACTURER: THIS LITERATURE WAS REGISTERED FOR ADVERSE EVENT: HERNIA RECURRENCE: ¿RECURRENT HERNIAS WERE DEFINED AS A HERNIA NEAR OR AT THE LOCATION OF A PREVIOUS REPAIR AND WERE DIAGNOSED CLINICALLY AND CONFIRMED WITH CT.¿ THERE WERE 2 NOTED HERNIA RECURRENCE IN THE GROUP THAT USED SURGIMEND. HTTPS://DOI.ORG/10.1016/J.BJPS.2023.11.007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266301 SURGIMEND MATRIX - UNSPECIFIED N/A OXH TEI BIOSCIENCES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other