BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3142979 · Received May 30, 2013

    Report

    Report Number
    1287163-2013-00050
    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 #31 (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 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
    238469 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 305010 12010017

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention