BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY OVERDENTURE ABUTMENT

    MDR report key: 11840826 · Received May 18, 2021

    Report

    Report Number
    3001617766-2021-02646
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    February 4, 2021
    Report Date
    May 17, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    NHA
    UDI-DI
    10841307111511
    PMA / PMN Number
    K061319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    LOT INFORMATION IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTARY REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4) AFTER CLINICAL PROCEDURE, BROKEN OR FRACTURED COMPONENT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736695 LEGACY OVERDENTURE ABUTMENT DENTAL IMPLANT NHA IMPLANT DIRECT SYBRON MANUFACTURING LLC NA NI 10841307111511

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR