BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 2982371 · Received February 25, 2013

    Report

    Report Number
    1287163-2013-00019
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    January 6, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K103790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 #9 (TYPE II BONE). PRIMARY STABILITY AND OSSEOINTEGRATION WERE ACHIEVED. IMMEDIATELY EXTRACTION SITE WAS INVOLVED IN THE EVENT. THE CLINICIAN STATES THAT THE BUCCAL CORTICAL PLATE DEGRADED BUT REMAINING 3 WALLS INTACT WITH INTEGRATION. A FINAL PROSTHESIS WAS INSTALLED ON (B)(6) 2012. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO PAIN. MEDICAL HISTORY: HYPOTHYROIDISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79172 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 305010 12020029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention