BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANK C/X IMPL A14/D3.5/L14

    MDR report key: 16146288 · Received January 12, 2023

    Report

    Report Number
    3013111692-2023-29817
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    August 18, 2022
    Report Date
    January 12, 2023
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K140347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. DS IMPLANTS IS NOT THE MANUFACTURER OF THE ABUTMENT THAT CAUSED THE EVENT.

    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
    1392498 ANK C/X IMPL A14/D3.5/L14 IMPLANT, ENDOSSEOUS, ROOT-FORM DZE DENTSPLY IMPLANTS MANUFACTURING GMBH 468729

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention ABUTMENT