BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY 2 IMPLANT

    MDR report key: 11823985 · Received May 14, 2021

    Report

    Report Number
    3001617766-2021-02548
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 14, 2021
    Report Date
    July 21, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307101772
    PMA / PMN Number
    K192221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION. UPDATED SECTION B4 FOR REPORT SUBMISSION DATE AND B6 TO REPORT DEVICE EVALUATION RESULTS. UPDATED G1 FOR FOLLOW-UP REPORT SUBMITTER, G3 FOR AWARENESS DATE AND G6 FOR REPORT TYPE AND FOLLOW-UP NUMBER. UPDATED H2 FOR FOLLOW-UP TYPE, H3 FOR DEVICE EVALUATION STATUS AND H6 METHOD, RESULT AND CONCLUSION CODES. THIS COMPLAINT IS BEING SUBMITTED LATE DUE TO THE FURLOUGHS THAT RESULTED FROM THE GLOBAL PANDEMIC AND IS CAPTURED WITHIN DEVIATION (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722771 LEGACY 2 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 172711 10841307101772

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention