BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3012364 · Received January 29, 2013

    Report

    Report Number
    1287163-2013-00010
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 28, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K102981
    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) 2012, IN SITE #6 (TYPE I BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE IMPLANT WAS REMOVED ON (B)(6) 2012, DUE TO PAIN, MOBILITY. MEDICAL HISTORY: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40023 INFINITY DENTAL IMPLANT SYSTEM INTERNAL HEX DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 204110 12020099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention