BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUTRAK

    MDR report key: 8265468 · Received January 21, 2019

    Report

    Report Number
    3025141-2019-00013
    Event Type
    Injury
    Date Received
    January 21, 2019
    Report Date
    January 4, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATES WITH THIS ARTICLE: 3025141-2019-00012: CASE 1.

    Description of Event or Problem · 1

    AFTER IMPLANTATION OF AN ACUTRAK SCREW, THERE WAS NON UNION OF THE FRACTURE WITH VASCULAR PROXIMAL POLE ASSESSED. REVISION SURGERY WAS PERFORMED WITH NON VASCULARIZED BONE GRAFTING AND ACUTRAK SCREW FOUR MONTHS AFTER ORIGINAL SURGERY. FROM: COMPARISON OF HEADLESS SCREWS USED IN THE TREATMENT OF PROXIMAL NONUNION OF SCAPHOID BONE. AREL GERELI, UFUK NALBANTOGLU, ISMAIL UGUR SENER, BARIS KOCAOGLU, METIN TURKMEN. INTERNATIONAL ORTHOPAEDICS (SICOT). (2011) 35: 1031-1035.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58578 ACUTRAK SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention