BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTRAK SCREW

    MDR report key: 8290974 · Received January 30, 2019

    Report

    Report Number
    3025141-2019-00089
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Report Date
    January 22, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K944330
    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: 3025141-2019-00086: CASE 1, 3025141-2019-00087: CASE 2, 3025141-2019-00088: CASE 3.

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION OF AN ACUTRAK SCREW, THE PATIENT EXPERIENCED SUBTALAR JOINT PAIN IN THE LATERAL FOOT AT THE LEVEL OF THE SINUS TARSI POST OP. THE PATIENT WAS CLOSELY MONITORED AND NO REVISION SURGERY WAS PERFORMED. CASE 4. FROM: ARTICLE: IS THE USE OF HEADLESS COMPRESSION SCREWS APPROPRIATE IN ARTHROSCOPIC ANKLE ARTHRODESIS? OCQUDER, DURMUS ALI; FIRAT, AHMET; OZDEMIR, METLIN; TECIMEL, OSMAN. JOINT DISEASES AND RELATED SURGERY, 2017: 28(3): 171-176.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81431 ACUTRAK SCREW SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1