BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3252228 · Received July 25, 2013

    Report

    Report Number
    1287163-2013-00084
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    May 10, 2013
    Report Date
    July 23, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K103790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 #13 (TYPE III BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AN AUGMENTATION WAS PERFORMED AT THE TIME OF SURGERY USING NUOSS PARTICULATE BONE WHICH WAS ADDED TOWARDS THE SINUS FLOOR (MAXILLA). THE CLINICIAN STATES THAT THE PT WORE IMPLANT RETAINED COMPLETE DENTURE ON MAXILLA WHICH MAY HAVE EXERTED SLIGHT PRESSURE ON THE RIDGE. THE CLINICIAN REPORTS THAT THE PT COMPLAINED OF PAIN AT THE SITE. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO PAIN, MOBILITY. MEDICAL HISTORY: SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347179 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 304310 12120028

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention