BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOPATCH BOVINE PERICARDIUM

    MDR report key: 22376731 · Received July 1, 2025

    Report

    Report Number
    3002924436-2025-00023
    Event Type
    Injury
    Date Received
    July 1, 2025
    Report Date
    August 15, 2025
    Manufacturer
    TUTOGEN MEDICAL GMBH (TMI)
    Product Code
    GXQ
    PMA / PMN Number
    K132850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, NO UNIQUE IDENTIFIERS HAVE NOT BEEN PROVIDED. THEREFORE, A COMPREHENSIVE BATCH ANALYSIS REVIEW COULD NOT BE CONDUCTED. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 05/28/2025, RTI SURGICAL, INC. D/B/A EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN, CONDUCTED A LITERATURE REVIEW AND FOUND AN ARTICLE TITLED: EVALUATION OF THE SAFETY AND EFFECTIVENESS OF A SEALANT HEMOSTATIC PATCH FOR PREVENTING CEREBROSPINAL FLUID LEAKS IN CRANIAL SURGERY. SANCHEZ FERNANDEZ C, ET.AL; EXPERT REV MED DEVICES. 2021 NOV;18(11): 1111-1116. A RETROSPECTIVE STUDY INVOLVED 230 PATIENTS WHO UNDERWENT NEUROSURGICAL PROCEDURES REQUIRING DURAL CLOSURE BETWEEN OCTOBER 2013 AND NOVEMBER 2017. DURAL SUBSTITUTES UTILIZED IN THIS STUDY WERE: AUTOLOGOUS MUSCLE GRAFT, AUTOLOGOUS OR HETEROLOGOUS FASCIA LATA, COLLAGEN MATRIX GRAFT (DURAGEN®) AND TWO TYPES OF BOVINE PERICARDIUM GRAFT (TUTOPATCH® AND DURAGUARD®). TUTOGEN PRODUCT AND SIMILAR DEVICES WERE USED FOR DURAL CLOSURE (IN LABEL). TUTOPATCH WAS USED IN 11 PATIENTS IN THE PCC GROUP AND IN 20 PATIENTS IN THE CONTROL GROUP. COMPLICATIONS ARE REPORTED IN TABLE 4, INCLUDING CSF LEAK, EPIDURAL AND SUBDURAL HEMATOMA, SURGICAL INFECTION, MENINGITIS, HYDROCEPHALOUS. HOWEVER, THEY ARE ONLY ALLOCATED TO PCC OR CONTROL AND NOT THE INDIVIDUAL PRODUCTS. IT IS UNKNOWN WHICH COMPLICATIONS OCCURRED IN THE PATIENTS WHERE TUTOPATCH GRAFTS WERE IMPLANTED. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO EVERGEN FOR REVIEW. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313683 TUTOPATCH BOVINE PERICARDIUM BOVINE PERICARDIUM MEMBRANE GXQ TUTOGEN MEDICAL GMBH (TMI)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other