BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 2 IMPLANT

    MDR report key: 11877199 · Received May 25, 2021

    Report

    Report Number
    3001617766-2021-03018
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    December 13, 2020
    Report Date
    July 21, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307101765
    PMA / PMN Number
    K192221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP SUBMITTED FOR ADDITIONAL INFORMATION. UPDATED SECTION B4 FOR REPORT SUBMISSION 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. PATIENT WEIGHT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    PATIENT'S WEIGHT AND IMPLANT DATE WERE NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY 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
    775919 LEGACY 2 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 88775 10841307101765

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention