BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY3 IMPLANT

    MDR report key: 7787683 · Received August 15, 2018

    Report

    Report Number
    3001617766-2018-00193
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    January 8, 2018
    Report Date
    August 15, 2018
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307102113
    PMA / PMN Number
    K090234
    Removal / Correction Number
    HHE 854210 081518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), INTERNAL COMPLAINT WAS RECEIVED FROM (B)(4), INDICATING 1 UNIT WHERE THE SECOND PATIENT LABEL HAS THE INCORRECT LOT NUMBER. THE JOB ORDER/LOT # SHOULD BE LOT 99129. LABEL STATES LOT 99120. PART INSIDE IS 854210, WHICH MATCHES LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625468 LEGACY3 IMPLANT DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC 99129 10841307102113

    Patients

    Seq Age Sex Outcome Treatment
    1