BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNA UNIVERSAL PLATFORM IMPLANT CA

    MDR report key: 19750342 · Received July 16, 2024

    Report

    Report Number
    3004417597-2024-00024
    Event Type
    Injury
    Date Received
    July 16, 2024
    Date of Event
    November 25, 2020
    Manufacturer
    B.T.I. BIOTECHNOLOGY INSTITUTE S.L.
    Product Code
    DZE
    UDI-DI
    08435389812210
    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.

    Description of Event or Problem · 0

    THE CLINICIAN INDICATES THAT HE PLACED THE IMPLANT ON (B)(6) 2020 AND, DURING THE SECOND SURGERY (FOUR MONTHS LATER) IT WAS OBSERVED THAT THE IMPLANT HAD NOT OSSEOINTEGRATED. PATIENT WITH BONE QUALITY III. IN THE EVENT THE PATIENT EXPERIENCED: INFECTION AND MOUTH SORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722024 INTERNA UNIVERSAL PLATFORM IMPLANT CA DZE B.T.I. BIOTECHNOLOGY INSTITUTE S.L. IIPUCA4011 AI04813.Z 08435389812210

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention