BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRONA DENTAL SYSTEMS GMBH

    MDR report key: 7328934 · Received March 9, 2018

    Report

    Report Number
    2411236-2018-00003
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 9, 2018
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Product Code
    NHA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTIST REPORTS A FRACTURE OF ONE DENTAL ABUTMENT. ABUTMENT WAS PLACED ON (B)(6) 2016 SITE UNKNOWN. THE ABUTMENT WAS REMOVED ON (B)(6) 2018. ANOTHER ABUTMENT AND CROWN WAS SUCCESSFULLY PLACED IN THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171919 SIRONA DENTAL SYSTEMS GMBH TIBASE ABUTMENT NB A 5.0 L NHA SIRONA DENTAL SYSTEMS GMBH 08913

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other