BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY 3 IMPLANT

    MDR report key: 11862499 · Received May 21, 2021

    Report

    Report Number
    3001617766-2021-02834
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    February 17, 2019
    Report Date
    March 3, 2022
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307102038
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    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 D9 FOR DEVICE RETURN DATE, 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 1412.

    Additional Manufacturer Narrative · 1

    PATIENT'S IDENTIFIER AND WEIGHT WERE NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PMA/510(K) - NOT APPLICABLE.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), BEFORE CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758200 LEGACY 3 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 118634 10841307102038

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention