BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPIOS PERICARDIUM MEMBRANE

    MDR report key: 9350310 · Received November 20, 2019

    Report

    Report Number
    3002924436-2019-00009
    Event Type
    Injury
    Date Received
    November 20, 2019
    Report Date
    December 4, 2019
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    NPL
    PMA / PMN Number
    K142070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THERE IS NEITHER PATIENT INDIVIDUAL DATA NOR PRODUCT SPECIFIC DATA AVAILABLE, THE REPORTED ADVERSE EVENTS CANNOT BE ASSESSED ON AN INDIVIDUAL BASIS. NO CAUSALITY ASSESSMENT COULD BE PERFORMED ON AN INDIVIDUAL BASIS.

    Description of Event or Problem · 0

    A DOCTOR WITH 10 YEARS OF EXPERIENCE IN USING COPIOS PERICARDIUM MEMBRANE FOR DENTAL APPLICATIONS HAS PERFORMED APPROXIMATELY 10 CASES WITH THE XENOGRAFT PER YEAR. THE COPIOS PERICARDIUM MEMBRANE WAS USED WITH ALLOGRAFTS. THE EASE OF MANIPULATION AND PRODUCT AESTHETICS MET THE DOCTOR'S EXPECTATIONS. SEVERAL ATTEMPTS TO OBTAIN PATIENT AND PRODUCT INFORMATION WERE MADE WITHOUT SUCCESS.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIERS WERE NOT PROVIDED IN ORDER TO CONDUCT A COMPREHENSIVE RECORDS RE-REVIEW. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RTI SURGICAL, INC (RTI) AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY OWNED SUBSIDIARY OF RTI, RECEIVED A COMPLAINT ON 10/29/19. THE INFORMATION DOCUMENTED ON THE POST MARKET SURVEY FOR COPIOS PERICARDIUM MEMBRANES (CPMS) FOR DENTAL APPLICATIONS PERFORMED WITHIN THE PAST TWO YEARS INDICATED THAT 50 DENTAL PROCEDURES WERE PERFORMED AND SOME OF THE PATIENTS HAD EXPERIENCED <1% OF DEHISCENCE FAILED TISSUE AUGMENTATION AND BONE LOSS. FOR RESORPTION/LIQUIDATION, 1 5% OF THE PATIENTS EXPERIENCED THIS COMPLICATION. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141057 COPIOS PERICARDIUM MEMBRANE BOVINE PERICARDIUM MEMBRANE NPL TUTOGEN MEDICAL GMBH NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other