BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY INTERNAL HEX IMPLANT SYSTEM

    MDR report key: 4911628 · Received July 10, 2015

    Report

    Report Number
    1287163-2015-00072
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    March 11, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Product Code
    DZE
    PMA / PMN Number
    K102981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE IMPLANT DETERMINED THAT ALL THE PRODUCT'S DESIGN SPECIFICATIONS WERE MET. VISUAL EXAMINATION YIELDED NO UNUSUAL OR SPECIFIC FLAWS TO THE IMPLANT DESIGN. THE REPORTED EVENT HAS BEEN DETERMINED TO BE A PRE LOADING IMPLANT FAILURE. THIS IMPLANT LOSS SUGGESTS THAT THE SOURCE OF THE PROBLEM WAS LIKELY TO STEM FROM PROCEDURAL ERRORS AND/OR BONE QUALITY. PATIENT ORAL ANATOMY IS TO BE CLOSELY ASSESSED PRIOR TO PROCEDURE AS DESCRIBED IN THIS PRODUCT'S INSTRUCTIONS FOR USE. 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 INSTRUCTION FOR USE.

    Description of Event or Problem · 1

    IMPLANT BECAME MOBILE AND FAILED BEFORE PROSTHETIC RESTORATION. STABILITY AND OSSEOINTEGRATION WAS ACHIEVED. AT THE TIME OF IMPLANTATION, BONE AUGUMENTATION WAS PERFORMED ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448565 INFINITY INTERNAL HEX IMPLANT SYSTEM INFINITY INTERNAL HEX DZE ACE SURGICAL SUPPLY CO., INC. 203710 14050071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention