BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 2894244 · Received December 27, 2012

    Report

    Report Number
    1287163-2012-00108
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    September 4, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ACE SURGICLA SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K103790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2011 IN SITE #3 (TYPE III BONE). PRIMARY STABILITY AND OSSEOINTEGRATION WERE ACHIEVED. AN AUGMENTATION WAS PERFORMED USING ALLOGRAFT. THE IMPLANT WAS REMOVED ON (B)(6) 2012. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICLA SUPPLY CO. 305011 11090021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention