BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3152568 · Received June 5, 2013

    Report

    Report Number
    1287163-2013-00054
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K954513
    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 (TYPE II BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE CLINICIAN STATES THAT NON BONE INTEGRATION PAIN AND SORENESS WERE THE REASONS FOR REMOVAL. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO PAIN. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248727 INFINITY DENTAL IMPLANT SYSTEM INTERNAL HEX DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 203711 11120070

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention