BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOPATCH® BOVINE PERICARDIUM

    MDR report key: 22080737 · Received May 23, 2025

    Report

    Report Number
    3002924436-2025-00015
    Event Type
    Injury
    Date Received
    May 23, 2025
    Report Date
    July 11, 2025
    Manufacturer
    TUTOGEN MEDICAL, GMBH
    Product Code
    FTM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RTI GERMANY'S INVESTIGATION IS IN PROCESS. ONCE THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHORS BY TUTOGEN. TO DATE, NO RESPONSE HAS BEEN PROVIDED PER THEIR REQUESTS. AS NO UNIQUE PRODUCT IDENTIFIERS WERE PROVIDED, TUTOGEN COULD NOT PERFORM A BATCH DOCUMENTATION ANALYSIS ON THE TUTOPATCH XENOGRAFTS THAT WERE IMPLANTED. CONCLUSION: UTILIZATION OF TUTOPATCH BOVINE PERICARDIUM XENOGRAFTS IN WRAPPING THE DICED CARTILAGE FOR NASAL DORSUM AUGMENTATION OR AS THE CAMOUFLAGE MATERIAL OVER THE NASAL DORSUM AND NASAL TIP SKELETON IN EITHER PRIMARY OR SECONDARY RHINOPLASTY OPERATIONS CAN BE A WISE OPTION WITHOUT ANY ADVERSE ALLERGIC REACTION OR DONOR SITE MORBIDITY. OVERCORRECTION IS CONSIDERED SERIOUS DUE TO THE NEED OF MEDICAL INTERVENTION. CAUSALITY FOR OFF-LABEL USE IS CONSIDERED NOT APPLICABLE AS PER CONVENTION BY TUTOGEN. OFF-LABEL USE AND OVERCORRECTION ARE NOT LISTED IN THE CURRENT IFU FOR TUTOPATCH XENOGRAFTS. ALTHOUGH IMPLANT THERAPY IS HIGHLY SUCCESSFUL AND PREDICTABLE, IT IS NOT WITHOUT POSSIBLE EARLY AND/OR LATE COMPLICATIONS. OVERCORRECTION IS CONSIDERED TO BE RELATED TO THE SURGICAL PROCEDURE AND NOT TO THE TUTOPATCH XENOGRAFT.

    Description of Event or Problem · 0

    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: UTILIZATION OF TUTOPATCH® BOVINE PERICARDIUM XENOGRAFT FOR NASAL DORSUM AUGMENTATION IN PRIMARY AND SECONDARY RHINOPLASTIES. AUTHORS ARET ÇERÇI ÖZKAN AND ERDEM GÜVEN IN ISTANBUL, TURKEY. TURKISH JOURNAL OF EAR NOSE AND THROAT;2019;29(3):111-118. BETWEEN JANUARY 2017 AND JULY 2019, TUTOPATCH GRAFTS WERE USED IN EIGHT PATIENTS (3M, 5F) WHO UNDERWENT A NASAL DORSUM AUGMENTATION / RHINOPLASTY. TUTOPATCH WAS ALSO USED FOR NASAL DORSUM CAMOUFLAGE IN SIX PATIENTS (1M, 5F) HAVING RHINOPLASTY OPERATIONS. ONLY ONE MAJOR COMPLICATION WAS REPORTED DUE TO THE OVERCORRECTION OF THE NASAL DORSUM WITH A SMALL HUMP WAS OBSERVED IN THE SECONDARY RHINOPLASTY CASE NECESSITATING FURTHER REVISION. OF NOTE, NO UNIQUE SERIAL IDS OF THE TUTOPATCH® GRAFTS UTILIZED IN THE STUDY WERE DOCUMENTED IN THE ARTICLE. THE TUTOPATCH® GRAFTS WERE USED OFF LABEL. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO RTI FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321015 TUTOPATCH® BOVINE PERICARDIUM TUTOPATCH® FTM TUTOGEN MEDICAL, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other