BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTRAK SCREW

    MDR report key: 8272778 · Received January 23, 2019

    Report

    Report Number
    3025141-2019-00023
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Report Date
    January 11, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS FROM THIS ARTICLE: 3025141-2019-00022: CASE 1; 3025141-2019-00024: CASE 3; 3025141-2019-00025: CASE 4; 3025141-2019-00026: CASE 5; 3025141-2019-00027: CASE 6; 3025141-2019-00028: CASE 7; 3025141-2019-00029: CASE 8; 3025141-2019-00030: CASE 9; 3025141-2019-00031: CASE 10.

    Description of Event or Problem · 1

    PATIENT WITH SCAPHOID NON-UNION WAS TREATED WITH AN ACURAK SCREW. NON-UNION OF THE FRACTURE CONTINUED. CASE 2. FROM: "COMPARISON OF HERBERT AND ACUTRAK SCREWS IN THE TREATMENT OF SCAPHOID NON-UNION AND DELAYED UNION. GREGORY, JONATHAN J., MOHIL, RANDIP S., NG, AARON B., WARNER, JAMES G., HODGSON, STEPHEN P. ACTA ORTHOP. BELG., 2008, 74, 761-765."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62836 ACUTRAK SCREW SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1