BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 2982373 · Received February 25, 2013

    Report

    Report Number
    1287163-2013-00021
    Event Type
    Injury
    Date Received
    February 25, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K954513
    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) 2012 IN SITE #18 (TYPE IV BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE CLINICIAN STATES THAT ON (B)(6) 2011, THE FOLLOWING GRAFT MATERIALS WERE USED TO PREPARE THE IMPLANT SITE, CERASORB, BACTERIN MEMBRANE AND NOVA BONE PUTTY. INADEQUATE BONE QUALITY/QUANTITY, IMMEDIATE EXTRACTION SITE, ADJACENT TO AN ENDODONTIC TOOTH AND A PREVIOUS BONE AUGMENTATION WERE INVOLVED IN THE EVENT. THE CLINICIAN STATES THAT THE IMPLANT FAILED TO INTEGRATE. THE IMPLANT WAS REMOVED ON (B)(6) 2013. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79013 INFINITY DENTAL IMPLANT SYSTEM INTERNAL HEX DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 205110 11120003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention