BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (25-2431) XIVE TG PLUS IMPL D3.4/L9.5

    MDR report key: 11750333 · Received April 29, 2021

    Report

    Report Number
    9612468-2021-05199
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    July 22, 2020
    Report Date
    April 28, 2021
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)
    Product Code
    DZE
    PMA / PMN Number
    K073075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643558 (25-2431) XIVE TG PLUS IMPL D3.4/L9.5 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB) NA B150000164

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention