BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3093643 · Received May 1, 2013

    Report

    Report Number
    1287163-2013-00039
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ACE SURGICAL 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) 2013, IN SITE NUMBER 13 (TYPE II BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. IMMEDIATE EXTRACTION SITE WAS INVOLVED IN THE EVENT. THE CLINICIAN STATES THAT THE IMPLANT STARTED FORMING GRANULATION TISSUE ABOUT SIX WEEKS AFTER PLACEMENT. THE IMPLANT WAS REMOVED ON (B)(6) 2013. ANOTHER IMPLANT WAS SUCCESSFULLY PLACED AT THE REMOVAL SURGICAL PROCEDURE. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188987 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 305010 12060069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention