BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3214045 · Received July 3, 2013

    Report

    Report Number
    1287163-2013-00078
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 31, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    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) 2013 IN SITE # 30. PRIMARY STABILITY WAS NOT ACHIEVED. THE CLINICIAN STATES THAT THE IMPLANT SHEARED OFF DURING PLACEMENT. THE IMPLANT WAS REMOVED ON (B)(6) 2013. ANOTHER IMPLANT WAS NOT SUCCESSFULLY PLACED DURING THE SURGICAL PROCEDURE. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305167 INFINITY DENTAL IMPLANT SYSTEM INTERNAL HEX DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 204713 12020082

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention