BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNA UNIVERSAL PLUS PLATFORM IMPLANT CA

    MDR report key: 19806515 · Received July 23, 2024

    Report

    Report Number
    3004417597-2024-00039
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    September 28, 2021
    Manufacturer
    B.T.I. BIOTECHNOLOGY INSTITUTE S.L.
    Product Code
    DZE
    UDI-DI
    08435389811886
    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) 2021 AND ONE MONTH 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
    963894 INTERNA UNIVERSAL PLUS PLATFORM IMPLANT CA DZE B.T.I. BIOTECHNOLOGY INSTITUTE S.L. IIPSCA5055 AI03744.Z 08435389811886

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention