BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3181547 · Received June 17, 2013

    Report

    Report Number
    1287163-2013-00060
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K103790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2013 IN SITE #6 (TYPE II-III BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE CLINICIAN PERFORMED A BONE GRAFT USING ALLOSS. AN INFECTION WAS INVOLVED IN THE EVENT. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO INFECTION, SWELLING, FISTULA. MEDICAL HISTORY: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273731 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 303510 12060066

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention