BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY 3 IMPLANT

    MDR report key: 2950487 · Received February 6, 2013

    Report

    Report Number
    2016150-2013-00004
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 4, 2013
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING, LLC
    Product Code
    DZE
    PMA / PMN Number
    K090234
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, A DOCTOR REPORTED THAT A PT'S LEGACY 3 IMPLANT HAD A FAILURE APPROXIMATELY 2 YEARS AND FOUR MONTHS AFTER IMPLANTED DUE TO AN X-RAY SHOWING THAT THERE WAS A FRACTURE IN THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50927 LEGACY 3 IMPLANT IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING, LLC 27060

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention