BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNAL HEX IMPLANT

    MDR report key: 5877053 · Received August 15, 2016

    Report

    Report Number
    1287163-2016-50612
    Event Type
    Injury
    Date Received
    August 15, 2016
    Date of Event
    February 15, 2016
    Report Date
    July 19, 2016
    Manufacturer
    ACE SURGICAL SUPPLY COMPANY
    Product Code
    DZE
    UDI-DI
    00614950004683
    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 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. 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529430 INTERNAL HEX IMPLANT DENTAL IMPLANT DZE ACE SURGICAL SUPPLY COMPANY 204108 15040007 00614950004683

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention