BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS PERICARDIUM MEMBRANE

    MDR report key: 22764822 · Received August 8, 2025

    Report

    Report Number
    3002924436-2025-00024
    Event Type
    Injury
    Date Received
    August 8, 2025
    Report Date
    October 28, 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

    FOLLOW UP #02 SUBMITTED TO ADD THE CODE FOR DEHISCENCE DESCRIBED IN FOLLOW UP REPORT #01. INVESTIGATION FINDINGS AND CONCLUSION DID NOT CHANGE.

    Additional Manufacturer Narrative · 0

    TUTOGEN CONDUCTED A BATCH DOCUMENTATION REVIEW FOR SERIAL ID (B)(6) MANUFACTURED FROM LOT NZA23100045. BATCH DOCUMENTATION REVIEW INDICATED THAT SERIAL ID (B)(6) WAS MANUFACTURED TO SPECIFICATION AND MET ALL ACCEPTANCE / INSPECTION CRITERIA PRIOR TO DISTRIBUTION. NO DEPARTURES FROM STANDARD OPERATING PROCEDURES WERE NOTED DURING THE RE-REVIEW FOR LOT NZA23100045. TUTOGEN HAS MANUFACTURED AND DISTRIBUTED (B)(4) COPIOS PERICARDIUM MEMBRANE XENOGRAFTS FROM LOT NZA23100045 WITHOUT RELATED COMPLAINTS. ALTHOUGH IMPLANT THERAPY IS HIGHLY SUCCESSFUL AND PREDICTABLE, IT IS NOT WITHOUT POSSIBLE EARLY AND/OR LATE COMPLICATIONS. DEHISCENCE, INFLAMMATION AND LOSS OF GINGIVAL THICKNESS (FOREIGN BODY REACTION) ARE BOTH ASSESSED AS NON-SERIOUS. FOREIGN BODY REACTION AND DEHISCENCE ARE LISTED IN THE CURRENT VALID IFU FOR COPIOS PERICARDIUM MEMBRANE. GINGIVAL RECESSION IS USUALLY CAUSED BY LOCAL INFLAMMATION (WITH OR WITHOUT INFECTION), WHICH FREQUENTLY ACCOMPANIES A DENTAL PROCEDURE. IT IS MORE PLAUSIBLE THAT THE POST-OPERATIVE COMPLICATIONS ARE ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE COPIOS PERICARDIUM MEMBRANE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RTI SURGICAL, INC. D/B/A EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN, RECEIVED ADDITIONAL INFORMATION THAT INDICATED THE FOLLOWING: THE PATIENT IS A NON-SMOKER WITH VERY GOOD ORAL HYGIENE AND NO BRUXISM. HER DENTAL PROCEDURE CONSISTED OF A LASER INCISION, FORMATION OF A MUCOPERIOSTEAL FLAP, EXPOSURE OF THE BONE, REMOVAL OF SOFT TISSUE FROM THE BONE, IMPLANT DRILLING, PERIOSTEAL INCISION WITH A SCALPEL, BONE FRESHENED WITH A ROSE HEAD BUR AROUND THE AREA TO BE AUGMENTED, COLLECTED AUTOGENOUS BONE FOR AUGMENTATION, REMOVED STERILE COPIOS PERICARDIUM MEMBRANE AND ROUNDED THE CORNERS WITH STERILE SCISSORS, COPIOS PERICARDIUM MEMBRANE WAS IMPLANTED, 1-2 DROPS OF STERILE NACL APPLIED TO MOISTEN, MEMBRANE ADAPTED UNDER PERIOSTEUM, FLAP ADAPTED AND SUTURED WITH SUPRAMID 4/0 WITHOUT SUTURING THE COPIOS PERICARDIUM MEMBRANE, SALIVA-TIGHT CLOSURE. ABOUT TWO WEEKS AFTER THE PROCEDURE, THE SUTURES WERE REMOVED, DEHISCENCE WAS OBSERVED, AND THE MUCOUS MEMBRANE WAS IRRITATED AT ITS EDGE. ONE WEEK LATER, MUCOSA HAD FORMED OVER THE MEMBRANE. ALTHOUGH THE REPORTER INITIALLY STATED THAT SHE SAW A CONNECTION BETWEEN THE GUM RECESSION AND THE TUTOGEN PRODUCT, THE COPIOS PERICARDIUM MEMBRANE WAS NOT REMOVED. FORMATION OF THE MUCOUS MEMBRANE SEEMED TO HAVE BEEN DELAYED, BUT THE HEALING PROCESS WAS NOT COMPLETELY INTERRUPTED. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO EVERGEN FOR REVIEW. .

    Description of Event or Problem · 0

    ON 07/09/2025, RTI SURGICAL, INC. D/B/A EVERGEN AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF EVERGEN, RECEIVED A COMPLAINT THAT INDICATED THAT A 58-YEAR-OLD FEMALE PATIENT UNDERWENT A DENTAL PROCEDURE ON (B)(6) 2025 WITH IMPLANTATION OF A COPIOS PERICARDIUM MEMBRANE. ON AN UNKNOWN DATE, IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT HAD A GINGIVAL REACTION TO THE MEMBRANE WHICH RESULTED IN THE LOSS OF GINGIVAL THICKNESS BY 2MM. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO EVERGEN FOR REVIEW. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161591 COPIOS PERICARDIUM MEMBRANE BOVINE PERICARDIUM MEMBRANE, PRODUCT CODE NPL NPL TUTOGEN MEDICAL GMBH (TMI) NZA23100045

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other