BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 2800744 · Received October 17, 2012

    Report

    Report Number
    1287163-2012-00097
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 16, 2012
    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 IV BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. A RIDGE AND SINUS AUGMENTATION WAS PERFORMED ON (B)(6) 2012. THE CLINICIAN STATES THAT THE PT DEVELOPED A POST OP INFECTION. THE IMPLANT WAS REMOVED ON (B)(6) 2012, DUE TO AN INFECTION. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITY DENTAL IMPLANT SYSTEM INTERNAL HEX DNETAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 204110 11120036

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention