BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS 4.5 IMPLANT

    MDR report key: 12040514 · Received June 21, 2021

    Report

    Report Number
    MW5102006
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 17, 2021
    Manufacturer
    DENTSPLY IH INC.
    Product Code
    NHA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    FRACTURE OF ANKYLOS DENTAL IMPLANT PLACED BY ORAL SURGEON (B)(6) 2008. IMPLANT FRACTURED MESIAL-DISTAL. NECESSITATES REMOVAL OF IMPLANT AND REPLACEMENT. PT REFERRED TO ORIGINAL ORAL SURGEON FOR REMOVAL AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934200 ANKYLOS 4.5 IMPLANT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA DENTSPLY IH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention