BEUDAMED
    FDA Adverse Event Summary report: N

    TWO-STEP IMPLANT

    MDR report key: 6081466 · Received November 7, 2016

    Report

    Report Number
    3007420745-2016-00002
    Date Received
    November 7, 2016
    Date of Event
    March 7, 2016
    Report Date
    November 4, 2016
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HWC
    PMA / PMN Number
    K122959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO CONTACT THE FACILITY REGARDING THE EVENT AND INVESTIGATION HAVE BEEN MADE. NO RESPONSE OR INFORMATION RECEIVED AS OF 11/04/2016.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THE MISPLACEMENT OF 3 TWO-STEP IMPLANTS. THE MANUFACTURER WAS NOTIFIED AFTER PATIENT COMPLAINED OF PAIN AND DISCOMFORT DUE TO MISPLACEMENT OF IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733398 TWO-STEP IMPLANT BONE SCREW HWC TRILLIANT SURGICAL, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention