BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOPATCH

    MDR report key: 21860656 · Received April 17, 2025

    Report

    Report Number
    3002924436-2025-00009
    Event Type
    Injury
    Date Received
    April 17, 2025
    Report Date
    June 20, 2025
    Manufacturer
    TUTOGEN MEDICAL GMBH (TMI)
    Product Code
    GXQ
    PMA / PMN Number
    K132850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TUTOGEN MEDICAL GMBH (TMI) WILL CONDUCT A COMPREHENSIVE RECORDS REVIEW (IF SERIAL OR DONOR NUMBERS ARE PROVIDED). WHEN COMPLETED A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    PSEUDOMENINGOCELE AND ASEPTIC MENINGITIS ARE BOTH CONSIDERED SERIOUS, AS THE PATIENT WAS TREATED WITH STEROIDS AND NEEDED SURGICAL REVISION. SPECIFIC RISK FACTORS HAVE NOT BEEN REPORTED APART FROM VARIOUS LIQUOR CIRCULATION ISSUES. THE AUTHORS DESCRIBE THE EVENT AS PROCEDURE-RELATED AND NOT DEVICE­ RELATED. BATCH DOCUMENTATION ANALYSIS CANNOT BE PERFORMED AS THE PRODUCT IDS HAVE NOT BEEN PROVIDED. HOWEVER, CSF LEAKAGE AND ASEPTIC MENINGITIS ARE FREQUENT COMPLICATIONS AFTER DURAPLASTY DUE TO SURGICAL CHALLENGES IN REGARD TO THE ANATOMICAL SITUATION. THEREFORE, TUTOGEN CONCURS WITH THE AUTHORS AND CONSIDERS ASEPTIC MENINGITIS AND PSEUDOMENINGOCELE AS NOT RELATED TO TUTOPATCH.

    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 A AN ARTICLE FOUND THROUGH LITERATURE SEARCH. "PILOT STUDY TO ASSESS THE SAFETY AND EFFICACY OF HUMAN ACELLULAR DERMAL MATRIX FOR CHIARI SURGERY", NEUROCIRUGIA (ASTUR: ENGLISH EDITION) 2025 FEB 27; TEIXIDOR-RODRIGUEZ P. ET AL. THE PUBLICATION PROVIDES THE RESULTS OF A UNICENTRIC STUDY ON DURAPLASTY IN CHIARI MALFORMATION, ONE GROUP PROSPECTIVE WITH PATIENTS TREATED WITH HUMAN ACELLULAR DERMIS MATRIX (HADM) AND ANOTHER GROUP THAT RETROSPECTIVELY ACQUIRED SURGICAL TREATMENT WITH TUTOPATCH®. THERE WERE NINETEEN PATIENTS IN EACH GROUP. THERE WERE NO COMPLICATIONS REPORTED FOR THE HADM GROUP. SEVEN PATIENTS IN THE TUTOPLAST GROUP DEVELOPED POST OPERATIVE COMPLICATIONS AS FOLLOWS: PSEUDOMENINGOCELE (3 PATIENTS; ONE REQUIRED A LUMBOPERITONEAL SHUNT), PSEUDOMENINGOCELE AND ASEPTIC MENINGITIS (2 PATIENTS, ONE RECOVERED AFTER CORTICOSTEROIDS TREATMENT, THE OTHER ONE REQUIRED SURGICAL INTERVENTION AND CORTICOSTEROID TREATMENT), AND ASEPTIC MENINGITIS (2 PATIENTS, RECOVERED WITH CORTICOSTEROID TREATMENT). THIS REPORT PERTAINS TO PATIENT #14 WHO DEVELOPED A PSEUDOMENINGOCELE AND ASEPTIC MENINGITIS WHO REQUIRED SURGICAL REVISION OF THE WOUND AND CORTICOSTEROID TREATMENT.

    Description of Event or Problem · 0

    PATIENT #14-TUTOPATCH GROUP (36 YEARS, SEX UNKNOWN) WAS INCLUDED IN A UNICENTRIC PROSPECTIVE STUDY TO ASSESS SAFETY AND EFFICACY OF TUTOPATCH, AND A HUMAN ACELLULAR DERMAL MATRIX (HADM) FOR DUROPLASTY DURING CHIARI SURGERY. AFER CHIARI SURGERY, THE SERIOUS EVENTS (REQUIRED MEDICAL INTERVENTION) OF PSEUDOMENIGOCELE AND ASEPTIC MENINGITIS OCCURRED (START DATE NOT REPORTED). MENINGITIS WAS TREATED WITH CORTICOSTEROID THERAPY. HOWEVER, THE OUTCOME OF THE EVENT WAS NOT REPORTED. AS PSEUDOMINGOCELE DID NOT REQUIRED SURGICAL TREATMENT, THE EVENT IS CONSIDERED RESOLVED. THE AUTHORS CONSIDERED NONE OF THE ADVERSE EVENT OCCURRING IN THE ABOVE MENTIONED TRIAL AS DEVICE -RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733214 TUTOPATCH TUTOPATCH BOVINE PERICARDIUM GXQ TUTOGEN MEDICAL GMBH (TMI)

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Unknown Other