BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNAL HEX IMPLANT

    MDR report key: 6595597 · Received May 26, 2017

    Report

    Report Number
    1287163-2017-50991
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    January 20, 2017
    Report Date
    May 9, 2017
    Manufacturer
    ACE SURGICAL SUPPLY COMPANY
    Product Code
    DZE
    UDI-DI
    00614950004690
    PMA / PMN Number
    K102981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT HAS BEEN DETERMINED TO BE 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. ADDITIONALLY, OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE IMPLANT FAILURE INCLUDES BONE CONDITION, PATIENT ORAL HYGIENE, OR PATIENT BEHAVIOR. PROPER INTENDED USE OF THE IMPLANT IS DESCRIBED IN ITS INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    PAIN WAS REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE WAS TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS UP TO 1 YR AFTER PROSTHETIC RESTORATION. PRIMARY STABILITY AND OSSEOINTEGRATION WAS NOT ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374418 INTERNAL HEX IMPLANT DENTAL IMPLANT DZE ACE SURGICAL SUPPLY COMPANY 204110 15050037 00614950004690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention