BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3072387 · Received April 19, 2013

    Report

    Report Number
    1287163-2013-00038
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    February 4, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K954513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 #14 (TYPE 1I BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE IMPLANT WAS REMOVED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170834 INFINITY DENTAL IMPLANT SYSTEM INTERNAL HEX DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 204710 1202007C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention