BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (17-0342) ANK IMPL A8 D3.5 MM/L8 MM(IMPLANTS)

    MDR report key: 11767550 · Received May 3, 2021

    Report

    Report Number
    9612468-2021-11645
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    June 24, 2019
    Report Date
    April 27, 2021
    Manufacturer
    DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)
    Product Code
    DZE
    PMA / PMN Number
    K040946
    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
    655657 (17-0342) ANK IMPL A8 D3.5 MM/L8 MM(IMPLANTS) IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention