BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3142980 · Received May 30, 2013

    Report

    Report Number
    1287163-2013-00048
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    January 30, 2013
    Report Date
    May 29, 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) 2012 IN SITE #29 (TYPE I-II BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AN INFECTION WAS INVOLVED IN THE EVENT. THE CLINICIAN STATES THAT THE PT HAS A DIABETIC CONDITION. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO INFECTION. MEDICAL HISTORY: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239682 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 304311 11090013

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention