BEUDAMED
    FDA Adverse Event Summary report: N

    UNK

    MDR report key: 4131222 · Received August 19, 2014

    Report

    Report Number
    3004983210-2014-00019
    Date Received
    August 19, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 23, 2014
    Manufacturer
    TORNIER INC.,
    Product Code
    KWH
    PMA / PMN Number
    K943354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    SURGEON IMPLANTED THE TRIAL INSTEAD OF THE IMPLANT. NURSE NOTICED THAT THE IMPLANT WAS NOT IMPLANTED AFTER THE CASE AND THEY LEFT THE TRIAL IN AFTER THE PT WAS CLOSED. THE DOCTOR WAS NOT CONCERNED AND SAID THE TRIAL WAS STERILE SO THEY LEFT THE TRIAL IN THE PT. HOSP CALLED AND ASKED WHAT MATERIAL MAKES UP THE TRIAL THAT WAS LEFT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500207 UNK UNK KWH TORNIER INC.,

    Patients

    Seq Age Sex Outcome Treatment
    1