BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOPATCH

    MDR report key: 22327697 · Received June 25, 2025

    Report

    Report Number
    3002924436-2025-00021
    Event Type
    Injury
    Date Received
    June 25, 2025
    Report Date
    September 2, 2025
    Manufacturer
    TUTOGEN MEDICAL GMBH (TMI)
    Product Code
    GXQ
    PMA / PMN Number
    K132850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE BATCH REVIEW IS BEING CONDUCTED. ONCE RESULTS ARE AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    IN TOTAL, (B)(4) PATIENTS (B)(4) RECEIVED TUTOPATCH. TWENTY PATIENTS DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK. NINE PATIENTS UNDERWENT REVISION SURGERY. TWO PATIENTS RECEIVED A VENTRICULOPERITONEAL (VP) SHUNT DUE TO THE DEVELOPMENT OF A HYDROCEPHALUS. THE AUTHORS OF THE ARTICLE DID NOT PROVIDE A CAUSALITY ASSESSMENT REGARDING THE TUTOPATCH GRAFTS (OR THE OTHER MATERIALS USED). A TEMPORAL RELATIONSHIP WAS NOT DESCRIBED AND CAN HENCE NOT BE ASSESSED. A BATCH DOCUMENTATION ANALYSIS COULD NOT BE PERFORMED AS PRODUCT IDS WERE NOT INITIALLY REPORTED NOR PROVIDED AFTER TUTOGEN MADE SEVERAL FOLLOW-UP ATTEMPTS. ALTHOUGH IMPLANT THERAPY IS HIGHLY SUCCESSFUL AND PREDICTABLE, IT IS NOT WITHOUT POSSIBLE EARLY AND/OR LATE COMPLICATIONS. ALL THE ADVERSE EVENTS DOCUMENTED IN THE ARTICLE ARE CONSIDERED SERIOUS BECAUSE THEY REPRESENT A DETERIORATION OF THE PATIENTS' HEALTH WHICH REQUIRED MEDICAL INTERVENTION. CSF LEAK IS LISTED IN THE CURRENT VALID IFU FOR TUTOPATCH. THE NEED FOR A REVISION SURGICAL PROCEDURE AND THE DEVELOPMENT OF A HYDROCEPHALUS WITH NECESSARY SHUNT PLACEMENT ARE NOT LISTED IN THE CURRENT IFU. SINCE THERE IS NO EVIDENCE POINTING TO A CAUSATIVE ROLE OF THE TUTOPATCH GRAFTS, THIS CASE IS ASSESSED AS NOT RELATED. TUTOGEN CONSIDERS THIS CASE CLOSED SINCE NO NEW INFORMATION IS EXPECTED TO BE PROVIDED.

    Description of Event or Problem · 0

    RTI SURGICAL INC, D/B/A EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN, RECEIVED A COMPLAINT ASSOCIATED WITH AN ARTICLE FOUND THROUGH A LITERATURE SEARCH. WHICH TYPE OF DURAPLASTY IS BEST FOR CHIARI TYPE I MALFORMATION SURGERY? L. G. VALENTINI, MD, ET.AL.; NEUROLOGICAL FOCUS, 2025, 58(2):E13. THE STUDY INVESTIGATED WHETHER THE SELECTION OF DIFFERENT DURAL SUBSTITUTES AND DISTINCT DURAL REPAIR TECHNIQUES CORRELATES WITH THE INCIDENCE RATE OF POSTOPERATIVE CSF LEAK IN A MIXED POPULATION OF ADULTS AND CHILDREN (DATA FROM 409 PATIENTS). THE FOLLOWING TREATMENT GROUPS WITH TUTOGEN PRODUCTS WERE INCLUDED: TUTOPATCH WITH DURAGEN (GROUP 4; 68 PATIENTS) AND TUTOPATCH ALONE (GROUP 5; 45 PATIENTS). IN ADDITION, DURAGEN AS SIMILAR DEVICE FOR TUTOPATCH WAS USED IN SEVERAL TREATMENT GROUPS. CSF LEAKS WERE: 12 PATIENTS (17.6%) IN GROUP 4, AND 8 PATIENTS (17.7%) IN GROUP 5. FIVE PATIENTS (7.3%) IN GROUP 4, AND 4 PATIENTS (8.8%) IN GROUP 5 NEEDED REVISION. FURTHER COMPLICATIONS HAVE NOT BEEN REPORTED. INDIVIDUAL PATIENT DATA ARE NOT PROVIDED (EVEN THE SUPPLEMENTAL MATERIAL ONLY PROVIDES MEANS PER GROUP). TUTOPATCH WAS USED IN-LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290634 TUTOPATCH TUTOPATCH BOVINE PERICARDIUM GXQ TUTOGEN MEDICAL GMBH (TMI)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other