BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIS

    MDR report key: 8142533 · Received December 7, 2018

    Report

    Report Number
    3007289093-2018-00031
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 7, 2018
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HWC
    PMA / PMN Number
    K171018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AXIS REMOVAL TOOK PLACE (B)(6) 2018. THE PATIENT COMPLAINED OF PAINFUL HARDWARE. X-RAYS WERE TAKEN, AND SHOWED THAT THE BEAM HAD BROKEN. THE BEAM WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982760 AXIS BONE SCREW HWC EXTREMITY MEDICAL, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention