BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3213803 · Received July 3, 2013

    Report

    Report Number
    1287163-2013-00071
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    February 27, 2013
    Report Date
    June 28, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K103790
    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 #10 (TYPE II BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AN AUGMENTATION WAS PERFORMED AT THE TIME OF SURGERY USING NUOSS 2.0 AND AN RCM6 MEMBRANE PLACED OVER THE IMPLANTS. THE CLINICIAN STATES LACK OF OSSEOINTEGRATION AT THE TIME OF ABUTMENT PLACEMENT. THE IMPLANT WAS REMOVED ON (B)(6) 2013. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303628 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 303511 12020004

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention