BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVINE PERICARDIUM MEMBRANE

    MDR report key: 7306842 · Received March 1, 2018

    Report

    Report Number
    3002924436-2018-00002
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    January 31, 2018
    Report Date
    March 1, 2018
    Manufacturer
    TUTOGEN MEDICAL GMBH
    Product Code
    NPL
    PMA / PMN Number
    K073097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO UNIQUE LOT OR SERIAL NUMBERS WERE PROVIDED RTI WAS UNABLE TO CONDUCT AN INVESTIGATION. IF ADDITIONAL INFORMATION IS PROVIDED A MANUFACTURING, LOT RECORDS REVIEW WILL BE CONDUCTED.

    Description of Event or Problem · 1

    RTI SURGICAL INC (RTI) AND TUTOGEN MEDICAL (B)(4), A WHOLLY OWNED SUBSIDIARY OF RTI RECEIVED A COMPLAINT WHICH INDICATED THAT A PERICARDIUM MEMBRANE AND COPIOS CANCELLOUS PARTICLES WERE IMPLANTED AS PART OF A DENTAL PROCEDURE ON UNKNOWN DATE AND LATER IT WAS REPORTED THAT THE MATERIAL BONE GRAFT AND MEMBRANE DID NOT INTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150997 BOVINE PERICARDIUM MEMBRANE DENTAL PERICARDIUM MEMBRANE NPL TUTOGEN MEDICAL GMBH NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other