BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (17-0564) ANK C/X IMPL C11/D5.5/L11(IMPLANTS)

    MDR report key: 11919533 · Received June 2, 2021

    Report

    Report Number
    9612468-2021-40240
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    January 15, 2020
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT IS REPORTABLE PER 21 CFR PART 803.

    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
    815226 (17-0564) ANK C/X IMPL C11/D5.5/L11(IMPLANTS) IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention