BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY TRI-CAM DENTAL IMPLANT

    MDR report key: 5123152 · Received October 2, 2015

    Report

    Report Number
    1287163-2015-50125
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    June 7, 2015
    Report Date
    October 1, 2015
    Manufacturer
    ACE SURGICAL SUPPLY COMPANY
    Product Code
    NHA
    PMA / PMN Number
    K103790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THAT THE IMPLANT MET THE SPECIFICATIONS AND WERE APPROVED FOR PRODUCT RELEASE. ACE SURGICAL HAS NOT BEEN ISSUED THE FAILED IMPLANT. PHYSICAL ANALYSIS CANNOT BE PERFORMED. THE REPORTED EVENT HAS BEEN DETERMINED TO BE A POST-PLACEMENT/PRE-LOAD IMPLANT FAILURE. THIS IMPLANT LOSS SUGGESTS THAT THE SOURCE OF THE PROBLEM WAS LIKELY TO STEM FROM PROCEDURAL ERRORS AND/OR THE LACK OF OSSEOINTEGRATION. THE LOSS OF INTEGRATION OR THE NON-INTEGRATION OF AN ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE AS DESCRIBED IN THIS PRODUCT'S INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    LACK OF OSSEOINTEGRATION WAS THE CAUSE OF THE IMPLANT FAILURE. MOBILITY AND BONE LOSS WERE ALSO REPORTED. BONE QUALITY AT TIME OF FAILURE WAS REPORTED AS "REGULAR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652600 INFINITY TRI-CAM DENTAL IMPLANT TRI-CAM IMPLANT NHA ACE SURGICAL SUPPLY COMPANY 305016 13120005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R