BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 3 IMPLANT

    MDR report key: 11893504 · Received May 27, 2021

    Report

    Report Number
    3001617766-2021-03097
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 4, 2021
    Report Date
    March 30, 2022
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307102007
    PMA / PMN Number
    K090234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED FOR ADDITIONAL INFORMATION.

    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.

    Additional Manufacturer Narrative · 1

    PATIENT'S IDENTIFIER, SEX AND OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS WERE NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. PATIENT'S AGE AND WEIGHT ARE UNKNOWN. 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), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED LACK OF PRIMARY STABILITY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791941 LEGACY 3 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 179916 10841307102007

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female