BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNAL HEX

    MDR report key: 11913475 · Received June 1, 2021

    Report

    Report Number
    1287163-2021-00849
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    March 13, 2020
    Report Date
    June 1, 2021
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Product Code
    DZE
    UDI-DI
    00614950004621
    PMA / PMN Number
    K102981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    BONE QUALITY WAS NOT IDENTIFIED. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED AT THE TIME OF SURGERY BUT IMPLANT DID NOT INTEGRATE WITH BONE AT RESTORATION. OSSEOINTEGRATION AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809532 INTERNAL HEX INTERNAL HEX IMPLANT DZE ACE SURGICAL SUPPLY CO., INC. 203708 18090089 00614950004621

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention