BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNA UNIVERSAL PLATFORM IMPLANT CA

    MDR report key: 20235783 · Received September 17, 2024

    Report

    Report Number
    3004417597-2024-00049
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    June 5, 2024
    Manufacturer
    B.T.I. BIOTECHNOLOGY INSTITUTE S.L.
    Product Code
    DZE
    PMA / PMN Number
    K151391
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BATCH DOCUMENTATION IS CHECKED AND NO ANOMALIES ARE DETECTED. ANY MANUFACTURING FAULT IS RULED OUT. AFTER EXAMINATION OF THE IMPLANT, IT CAN BE VERIFIED THAT THE IMPLANT DOES NOT SHOW SIGNS OF MISUSE OR SIGNS OF MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE EVENT. HOWEVER, IT IS FOUND THAT THE DRILLING PROTOCOL USED IS DIFFERENT FROM THE RECOMMENDED ONE.

    Description of Event or Problem · 0

    THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON 03/14/2024 AND THREE MONTHS LATER IT WAS NOTED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY IV. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901650 EXTERNA UNIVERSAL PLATFORM IMPLANT CA DZE B.T.I. BIOTECHNOLOGY INSTITUTE S.L. IRPUCA4075 BC05938.B

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention