BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS PERICARDIUM MEMBRANE

    MDR report key: 18791309 · Received February 27, 2024

    Report

    Report Number
    3002924436-2024-00001
    Event Type
    Injury
    Date Received
    February 27, 2024
    Report Date
    April 9, 2024
    Manufacturer
    TUTOGEN MEDICAL, GMBH
    Product Code
    NPL
    PMA / PMN Number
    K073097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RTI GERMANY CONDUCTED A BATCH DOCUMENTATION REVIEW FOR SERIAL ID (B)(6) MANUFACTURED FROM LOT NZA22090152. NO DEPARTURES FROM STANDARD OPERATING PROCEDURES WERE NOTED DURING THE RECORDS RE-REVIEW FOR THE LOT. RECORDS REVIEW INDICATED THAT SERIAL ID (B)(6) WAS MANUFACTURED TO SPECIFICATION AND MET ALL ACCEPTANCE / INSPECTION CRITERIA PRIOR TO DISTRIBUTION. TO DATE, RTI GERMANY HAS MANUFACTURED AND DISTRIBUTED 75 COPIOS PERICARDIUM MEMBRANE XENOGRAFTS FROM LOT NZA22090152 WITHOUT RELATED COMPLAINTS. ALTHOUGH IMPLANT THERAPY IS HIGHLY SUCCESSFUL AND PREDICTABLE, IT IS NOT WITHOUT POSSIBLE EARLY AND/OR LATE COMPLICATIONS. HYPOESTHESIA IS CONSIDERED A SYMPTOM OF THE INFECTION. THE TRANSPLANT FAILURE AND THE INFECTION ARE BOTH CONSIDERED SERIOUS AS PER COMPANY CONVENTION AND MEDICAL INTERVENTION RESPECTIVELY. INFECTIONS ARE FREQUENTLY CAUSED BY INSUFFICIENT STERILITY DURING SURGERY OR POSTOPERATIVELY. TRANSPLANT FAILURE AND INFECTIONS ARE BOTH LISTED IN THE CURRENT IFU. BATCH DOCUMENTATION ANALYSIS CONFIRMED THAT THE COPIOS PERICARDIUM MEMBRANE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE INVESTIGATION CONCLUDED THAT THE ADVERSE EVENT IS ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE PUROS ALLOGRAFT CUSTOMIZED BLOCK, PUROS SPONGIOSA PARTICLES, AND THE COPIOS PERICARDIUM MEMBRANE IMPLANT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RTI SURGICAL, INC. AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL, RECEIVED ADDITIONAL INFORMATION INDICATING THE FOLLOWING" THE PATIENT IS A 66-YEAR-OLD MALE WHO UNDERWENT A BONE AUGMENTATION ON (B)(6) 2023. THE PROCEDURE CONSISTED OF AN MP FLAP FOR IMPLANT PLACEMENT ON THE LOWER LEFT SIDE AT TOOTH SITES #35-#37, PERIOSTEAL SLITTING, AND TENSION-FREE CLOSURE. THE GRAFTS IMPLANTED CONSISTED OF A PUROS® ALLOGRAFT CUSTOMIZED BLOCK, SPONGIOSA PARTICLES, AND A COPIOS PERICARDIUM MEMBRANE. TWO SCREWS WERE UTILIZED FOR FIXATION. ON UNKNOWN DATES, THE PATIENT RETURNED FOR FOLLOW-UP WITH UNREMARKABLE RESULTS. ON (B)(6) 2023, THE PATIENT RETURNED FOR SUTURE REMOVAL. DURING THE PROCEDURE, CLOUDY SECRETION WAS SEEN ANTERIORLY FOR THE FIRST TIME. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ANTERIOR REVISION AND SMOOTHING WITH PLASTIC COVERAGE. AFTER THE PROCEDURE, THE PATIENT FELT BETTER AND THE WOUND WAS CLOSED. ON UNKNOWN DATES, THE PATIENT STILL EXPERIENCED PERSISTENT SYMPTOMS OF DISCOMFORT AT THE TOOTH SITES. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PARTIAL HYPOESTHESIA ON THE LEFT SIDE. ON (B)(6) 2024, AN ORTHOPANTOMOGRAM (OPT) WAS PERFORMED WHICH SHOWED A BRIGHTENING IN THE PUROS® ALLOGRAFT CUSTOMIZED BLOCK. FOUR DAYS LATER, ON (B)(6) 2024, THE PATIENT UNDERWENT ANOTHER REVISION PROCEDURE AND CURETTAGE. THE PUROS® ALLOGRAFT CUSTOMIZED BLOCK AND SCREWS WERE THEN EXPLANTED.

    Description of Event or Problem · 0

    ON 02/01/2024, RTI SURGICAL, INC. AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL, RECEIVED A COMPLAINT FROM ZIMVIE GERMANY. THE REPORTED COMPLAINT INDICATED THAT THE PATIENT UNDERWENT A BONE AUGMENTATION PROCEDURE AT TOOTH SITES #35-37. A PUROS® ALLOGRAFT CUSTOMIZED BLOCK AND A COPIOS PERICARDIUM MEMBRANE WERE IMPLANTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED LOSS OF INTEGRATION AND INFECTION WITH PERSISTENT DISCOMFORT AT THE TOOTH SITES. ON AN UNKNOWN DATE, THE GRAFT(S) WERE REMOVED. ON AN UNKNOWN DATE, THE PATIENT RETURNED FOR FOLLOW-UP AND UNDERWENT A CURETTAGE PROCEDURE. A NEW BONE AUGMENTATION PROCEDURE IS PLANNED FOR THE PATIENT. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO RTI FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668764 COPIOS PERICARDIUM MEMBRANE DENTAL MEMBRANE NPL TUTOGEN MEDICAL, GMBH NZA22090152

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other