BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 3 IMPLANT

    MDR report key: 11893529 · Received May 27, 2021

    Report

    Report Number
    3001617766-2021-03128
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 29, 2021
    Report Date
    August 27, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307102298
    PMA / PMN Number
    K090234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B4 FOR REPORT SUBMISSION DATE, G1 FOR CONTACT INFORMATION, G3 FOR AWARENESS DATE OF NEW INFORMATION, G6 FOR REPORT TYPE AND SECTIONS D9, H1, H2, H3, AND H6 TO REPORT THAT THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 WEIGHT WAS 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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793325 LEGACY 3 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 175328 10841307102298

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR