BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTRAK MINI

    MDR report key: 8275853 · Received January 24, 2019

    Report

    Report Number
    3025141-2019-00033
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Report Date
    January 11, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K930834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDR'S ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00032: CASE 1, 3025141-2019-00034: CASE 3, 3025141-2019-00035: CASE 4, 3025141-2019-00036: CASE 5.

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION OF AN ACUTRAK MINI SCREW IN THE HAND, FRACTURE AND PROXIMAL SCREW MIGRATION WERE PRESENT 12 WEEKS AFTER SURGERY. MANAGED WITH OBSERVATION AND UNION WAS OBSERVED AT 6 MONTHS POST OP. CASE 2. FROM: DISTAL INTERPHALANGEAL JOINT ARTHODESIS IN EXTENSION USING A HEADLESS COMPRESSIVE SCREW. KONAN, SUJITH; DAS, ADITI; TAYLOR, EMMA; SORENE, ELLIOT. ACTA ORTHOP. BELG., 2013, 79, 154-158.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68120 ACUTRAK MINI SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1