BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX SFS

    MDR report key: 7207861 · Received January 19, 2018

    Report

    Report Number
    2183449-2017-00035
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    December 19, 2017
    Report Date
    January 18, 2018
    Manufacturer
    ORTHOFIX INC.
    Product Code
    LXH
    PMA / PMN Number
    K122901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT THE TIP OF THE TAP BROKE OFF INTO THE PEDICLE. THE SURGEON TRIED TO EXTRACT THE BROKEN PIECE RESULTING IN A DELAY IN THE CASE. THE FRAGMENT OF THE INSTRUMENT WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48373 PHOENIX SFS CANNULATED TAP ASSEMBLY LXH ORTHOFIX INC. 20-0145 41444-RF04

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR