BEUDAMED
    FDA Adverse Event Injury Summary report: N

    17-3070) ANK REG C/ABUT GH 3.0 A 0 (IMPLANTS)

    MDR report key: 13258292 · Received January 14, 2022

    Report

    Report Number
    9612468-2022-00048
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    October 13, 2021
    Report Date
    January 13, 2022
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683039 17-3070) ANK REG C/ABUT GH 3.0 A 0 (IMPLANTS) IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Congenital Anomaly| R