BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 2 IMPLANT

    MDR report key: 10731977 · Received October 25, 2020

    Report

    Report Number
    3001617766-2020-07531
    Event Type
    Malfunction
    Date Received
    October 25, 2020
    Date of Event
    September 30, 2020
    Report Date
    January 4, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307101376
    PMA / PMN Number
    K192221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    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 D4 FOR CATALOG # AND UNIQUE IDENTIFIER (UDI) #, 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. DEVICE RECEIVED IS DIFFERENT FROM THE PART THAT WAS INDICATED ON THE INITIAL 3500A REPORT. LOT NUMBER AND MANUFACTURE/EXPIRATION DATES PREVIOUSLY SUBMITTED DO NOT APPLY. LOT NUMBER INFORMATION IS UNKNOWN. THIS COMPLAINT IS BEING SUBMITTED LATE DUE TO THE FURLOUGHS THAT RESULTED FROM THE GLOBAL PANDEMIC AND IS CAPTURED WITHIN DEVIATION (B)(4).

    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), DURING CLINICAL PROCEDURE, PRODUCT FRACTURED WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196739 LEGACY 2 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 158497 10841307101376

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR