BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGACY3 IMPLANT 3.7MMD X 8MML SBMPRODUCT CODE 853708

    MDR report key: 7281209 · Received February 19, 2018

    Report

    Report Number
    3001617766-2018-00011
    Event Type
    Injury
    Date Received
    February 19, 2018
    Date of Event
    April 24, 2017
    Report Date
    February 19, 2018
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    UDI-DI
    10841307102045
    PMA / PMN Number
    K090234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANTS WENT INTO MANDIBULAR CANAL AND CAUSED NUMBNESS OF LIP AND CHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123062 LEGACY3 IMPLANT 3.7MMD X 8MML SBMPRODUCT CODE 853708 DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC 853708 71172 10841307102045

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention