BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 3 IMPLANT

    MDR report key: 12015738 · Received June 17, 2021

    Report

    Report Number
    3001617766-2021-03598
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 18, 2021
    Report Date
    July 9, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307102069
    PMA / PMN Number
    K090234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION.

    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, IMPLANT FRACTURE AT DELIVERY OF PROSTHETIC RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917336 LEGACY 3 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 68141 10841307102069

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention