BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUTRAK PLUS

    MDR report key: 8278915 · Received January 25, 2019

    Report

    Report Number
    3025141-2019-00037
    Event Type
    Injury
    Date Received
    January 25, 2019
    Report Date
    January 11, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K944330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AN ACUTRAK PLUS SCREW WAS IMPLANTED IN THE PATIENT'S ANKLE. AT SEVEN DAYS POST OP, THE PATIENT WAS DIAGNOSED WITH "SUPERIFIAL" INFECTION OF THE WOUND. THE PATIENT WAS TREATED WITH ANTIBIOITCS AND THE WOUND HEALED. FROM ARTICLE: "LATERAL FIXATION OF AO TYPE-B2 ANKLE FRACTURES: THE ACUTRAK PLUS COMPRESSION SCREW TECHNIQUE." LEE, YIH-SHIUNN; HSU, TZU-LIANG; HUANG, CHIEN-RAE; CHEN, SHIH-HAO. INTERNATIONAL ORTHOPAEDICS (SICOT) (2010) 34: 903-907.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72629 ACUTRAK PLUS SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention