BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNA UNIVERSAL PLATFORM IMPLANT

    MDR report key: 19666520 · Received July 3, 2024

    Report

    Report Number
    3004417597-2024-00013
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    October 1, 2020
    Manufacturer
    B.T.I. BIOTECHNOLOGY INSTITUTE S.L.
    Product Code
    DZE
    UDI-DI
    08435389815136
    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, THERE IS A SMALL GAP BETWEEN THE IMPLANT AND THE COVER SCREW, AS WELL AS SIGNS OF INFECTION AROUND THIS AREA.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757219 EXTERNA UNIVERSAL PLATFORM IMPLANT DZE B.T.I. BIOTECHNOLOGY INSTITUTE S.L. IRPUCA3710 AH04383.Z 08435389815136

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention