BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3020621 · Received March 21, 2013

    Report

    Report Number
    1287163-2013-00023
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Product Code
    DZE
    PMA / PMN Number
    K954513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 #19 (TYPE II BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE CLINICIAN STATES THAT THE IMPLANT BECAME LOOSE. THE IMPLANT WAS REMOVED ON (B)(6) 2013. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118330 INFINITY DENTAL IMPLANT SYSTEM INTERNAL HEX DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO., INC. 204708 12010105

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention