BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTRAK SCREW

    MDR report key: 8290647 · Received January 30, 2019

    Report

    Report Number
    3025141-2019-00080
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Report Date
    January 22, 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 MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00078: CASE 1, 3025141-2019-00079: CASE 2, 3025141-2019-00081: CASE 4, 3025141-2019-00082: CASE 5, 3025141-2019-00083: CASE 6.

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION OF AN ACUTRAK SCREW, THE PATIENT EXPERIENCED CLASS I HETEROTOPIC OSSIFICATION (RADIOGRAPHICALLY DETECTED). NO REVISION SURGERY WAS PERFORMED. CASE 3. FROM: ARTICLE: LARGE CORONAL SHEAR FRACTURES OF THE CAPITELLUM AND TROCHLEA TREATED WITH HEADLESS COMPRESSION SCREWS. MIGHELL, MARK; VIRANI, NAZEEM A.; SHANNON, ROBERT; ECHOLS JR., EDDY L.; BADMAN, BRIAN L.; KEATING, CHRISTOPHER J. J SHOULDER ELBOW SRUG (2010) 19, 38-45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81373 ACUTRAK SCREW SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1