BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS PERICARDIUM MEMBRANE

    MDR report key: 22331461 · Received June 25, 2025

    Report

    Report Number
    3002924436-2025-00022
    Event Type
    Injury
    Date Received
    June 25, 2025
    Report Date
    August 15, 2025
    Manufacturer
    TUTOGEN MEDICAL GMBH (TMI)
    Product Code
    NPL
    PMA / PMN Number
    K073097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE BATCH RECORD ANALYSIS IS BEING CONDUCTED. ONCE THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WIL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    TUTOGEN CONDUCTED A BATCH ANALYSIS REVIEW FOR SERIAL ID (B)(6) MANUFACTURED FROM LOT NZA22500110. ONE DEPARTURE FROM THE STANDARD OPERATING PROCEDURES WAS NOTED DURING THE RECORDS RE-REVIEW FOR THE LOT. THE DEPARTURE DID NOT HAVE ANY NEGATIVE IMPACT ON THE TISSUE AND/OR PRODUCT QUALITY. PER THE BATCH ANALYSIS REVIEW, SERIAL ID (B)(6) WAS MANUFACTURED TO SPECIFICATION AND MET ALL ACCEPTANCE / INSPECTION CRITERIA PRIOR TO DISTRIBUTION. TO DATE, TUTOGEN HAS MANUFACTURED AND DISTRIBUTED 35 COPIOS PERICARDIUM XENOGRAFTS FROM LOT NZA22500110 WITHOUT RELATED COMPLAINTS. ALTHOUGH IMPLANT THERAPY IS HIGHLY SUCCESSFUL AND PREDICTABLE, IT IS NOT WITHOUT POSSIBLE EARLY AND/OR LATE COMPLICATIONS. THE CASE IS ASSESSED AS SERIOUS BECAUSE MEDICAL INTERVENTION WERE REQUIRED (INFECTION TREATED WITH ANTIBIOTICS AND BONE GRAFT FAILURE RESULTING IN REMOVAL). THE DEVELOPMENT OF INFLAMMATION AND WOUND DEHISCENCE ARE SYMPTOMS ASSOCIATED WITH THE INFECTION. INFECTION, INFLAMMATION, TRANSPLANT FAILURE AND DEHISCENCE ARE KNOWN EVENTS AND DESCRIBED IN THE CURRENT IFU. IT IS MORE PLAUSIBLE THAT THE POST-OPERATIVE COMPLICATIONS ARE ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE COPIOS PERICARDIUM MEMBRANE XENOGRAFT.

    Description of Event or Problem · 0

    ON 05/26/2025, RTI SURGICAL, INC. D/B/A EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN, RECEIVED A COMPLAINT THAT INDICATED A PATIENT UNDERWENT A DENTAL PROCEDURE WITH IMPLANTATION OF A PUROS ALLOGRAFT CUSTOMIZED BLOCK AND A COPIOS PERICARDIUM MEMBRANE ON (B)(6) 2024. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED AN INFECTION, DEHISCENCE, INFLAMMATION AND LOSS OF THE AUGMENTATION MATERIAL AT TOOTH SITE #22. THE GRAFTS WERE REMOVED ON (B)(6) 2024. THE PATIENT HAS BEEN RESCHEDULED FOR A SECOND SURGERY. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO EVERGEN FOR REVIEW. .

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED TO RTI SURGICAL INC. D/B/A EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN THAT INDICATED: A MONTH PRIOR TO EXTRACTION AT THE FOLLOW-UP APPOINTMENT, THE DENTIST NOTICED THAT THERE WERE SIGNS THAT THE PRIMARY WOUND CLOSURE HAD FAILED. AFTER A MONTH, SMALL "HOLES" OCCURRED IN THE BONE STRUCTURE, THAT BECAME MORE INFECTED OVER TIME. THE PATIENT THEN FINALLY ACCEPTED TO HAVE IT EXTRACTED. THE REBUILDING PROCESS HAD STARTED. AS LONG AS THERE WERE STILL SOME ISLES IN WHICH THE INFECTION SEEMED PARTICULARLY STRONG AND RESISTANT, THE DENTIST WANTED TO WAIT UNTIL HE DECIDED ON WHAT TO DO NEXT AND WHETHER HE WANTED TO TRY THE DENTAL PROCEDURE AGAIN. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO TUTOGEN FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327611 COPIOS PERICARDIUM MEMBRANE BOVINE PERICARDIUM MEMBRANE, PRODUCT CODE NPL NPL TUTOGEN MEDICAL GMBH (TMI) NZA22500110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other