BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 2 IMPLANT

    MDR report key: 11884406 · Received May 26, 2021

    Report

    Report Number
    3001617766-2021-03087
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Report Date
    May 26, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307101383
    PMA / PMN Number
    K192221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, IMPLANT AND EXPLANT DATES WERE NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. PATIENT'S AGE AND WEIGHT ARE UNKNOWN. LOT INFORMATION IS UNKNOWN. IF ADDITIONAL 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.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4) DURING CLINICAL PROCEDURE,COMPONENTS COULD NOT BE SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780657 LEGACY 2 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA NI 10841307101383

    Patients

    Seq Age Sex Outcome Treatment
    1