BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY EXTERNAL HEX DENTAL IMPLANT SYSTEM

    MDR report key: 5039653 · Received August 12, 2015

    Report

    Report Number
    1287163-2015-50117
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    June 26, 2015
    Report Date
    August 12, 2015
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Product Code
    DZE
    PMA / PMN Number
    K954513
    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 PATIENT'S BONE CONDITION, ORAL HYGIENE, OR BEHAVIOR MAY HAVE ALSO CONTRIBUTED TO THE FAILURE OF THE IMPLANT. 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. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    MOBILITY WAS REPORTED AS THE CAUSE OF THE IMPLANT FAILURE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532280 INFINITY EXTERNAL HEX DENTAL IMPLANT SYSTEM INFINITY EXTERNAL HEX DZE ACE SURGICAL SUPPLY CO., INC. 09231322 11030063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention