BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY 2 IMPLANT

    MDR report key: 11893505 · Received May 27, 2021

    Report

    Report Number
    3001617766-2021-03110
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    February 23, 2021
    Report Date
    June 11, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307101253
    PMA / PMN Number
    K192221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) #. UPDATED 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.

    Additional Manufacturer Narrative · 1

    PATIENT'S IDENTIFIER AND WEIGHT WERE 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 COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791944 LEGACY 2 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 160167 10841307101253

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention