BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY 2 IMPLANT

    MDR report key: 11937212 · Received June 4, 2021

    Report

    Report Number
    3001617766-2021-03321
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    January 21, 2021
    Report Date
    June 16, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307101321
    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.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. 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
    836481 LEGACY 2 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA 168301 10841307101321

    Patients

    Seq Age Sex Outcome Treatment
    1