BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS PERICARDIUM MEMBRANE

    MDR report key: 22285537 · Received June 18, 2025

    Report

    Report Number
    3002924436-2025-00018
    Event Type
    Injury
    Date Received
    June 18, 2025
    Report Date
    July 24, 2025
    Manufacturer
    TUTOGEN MEDICAL GMBH (TMI)
    Product Code
    NPL
    PMA / PMN Number
    K073097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A BATCH DOCUMENTATION ANALYSIS COULD NOT BE PERFORMED AS THE PRODUCT IDS HAD NOT BEEN REPORTED. THIS CASE FROM THE SCIENTIFIC LITERATURE (BRAUNER ET AL.) REFERS TO THE USE OF COPIOS PERICARDIUM MEMBRANE TOGETHER WITH THE USE OF CUSTOM­ MADE GBR TITANIUM MEMBRANES, DESIGNED THROUGH CAD-CAM TECHNOLOGY, IN 10 PATIENTS WITH SEVERE BONE DEFECTS REQUIRING DENTAL IMPLANT PLACEMENT. THE PROCEDURE WAS SUCCESSFUL IN ALL 10 PATIENTS, HOWEVER, TITANIUM MEMBRANE EXPOSURE LEADING TO EARLY REMOVAL OF THE MEMBRANE WAS REPORTED FOR THREE PATIENTS. THIS CASE REFERS TO PATIENT 06 (REPORTED WITH EARLY EXPOSURE). THE TITANIUM MEMBRANE WAS REMOVED AND EXCHANGED WITH ANOTHER MEMBRANE. IF COPIOS WAS ALSO USED FOR THE REPLACEMENT MEMBRANE HAS NOT BEEN REPORTED BUT IS ASSUMED FOLLOWING A WORST CASE SCENARIO. BOTH EVENTS (NOW WOUND DEHISCENCE AND GRAFT FAILURE) ARE CONSIDERED SERIOUS DUE TO REQUIRING SURGICAL INTERVENTION. THE AUTHORS DID NOT PROVIDE A CAUSALITY ASSESSMENT REGARDING THE COPIOS MEMBRANE. A TEMPORAL RELATIONSHIP WAS ALSO NOT DESCRIBED (ONLY EARLY AND LATE EXPOSURE). HOWEVER, BOTH EVENTS OCCURRED WITHIN THE TIME FRAME OF THE TESTED PROCEDURE.SINCE THERE IS NO REASONABLE POSSIBILITY FOR A CAUSAL RELATIONSHIP BETWEEN THE COPIOS MEMBRANE AND THE TWO EVENTS, THIS CASE IS ASSESSED AS NOT RELATED. THE TITANIUM MEMBRANE IS A STRONG CONFOUNDER.

    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. OPERATIONAL PROTOCOL FOR PROSTHETICALLY GUIDED RECONSTRUCTION OF EDENTULOUS SITES USING A CUSTOM-MADE TECHNIQUE; BRAUNER, E., ET. AL.; APPLIED SCIENCES, 2025, 15, 203. THE STUDY ON PROSTHETICALLY GUIDED RECONSTRUCTION OF EDENTULOUS SITES IN TEN PATIENTS USING A CUSTOM-MADE GBR-MEMBRANE DESIGNED BY CAD-CAM TECHNOLOGY. THE GBR-MEMBRANE WAS SUBSEQUENTLY REPLACED BY THE IMPLANT IN A SECOND SURGICAL STEP. COPIOS MEMBRANE WAS USED DURING THE FIRST SURGICAL PROCEDURE AS COVERAGE OF THE CUSTOM-MADE MEMBRANE. BONE GAIN COULD BE ACHIEVED IN ALL TEN PATIENTS; HOWEVER, MEMBRANE EXPOSURE (CUSTOM-MADE MEMBRANE) WAS REPORTED IN THREE PATIENTS (PATIENTS 5, 6 AND 7). LN ALL THREE CASES, THE CUSTOM-MADE MEMBRANE WAS REMOVED (FAILURE OF IMPLANT). ALL THREE PATIENTS WERE STILL ASSESSABLE FOR THE SECOND SURGICAL PHASE. THIS REPORT PERTAINS TO PATIENT #6 WHO EXPERIENCED FAILURE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748301 COPIOS PERICARDIUM MEMBRANE BOVINE PERICARDIUM MEMBRANE NPL TUTOGEN MEDICAL GMBH (TMI)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other