BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUTRAK SCREW

    MDR report key: 8290967 · Received January 30, 2019

    Report

    Report Number
    3025141-2019-00088
    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, 3025141-2019-00089: CASE 4.

    Description of Event or Problem · 1

    GUIDE WIRE BREAKAGE DEVELOPED DURING PLACEMENT OF AN ACUTRAK SCREW. NO REVISION SURGERY WAS PERFORMED. CASE 3. 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
    81434 ACUTRAK SCREW SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1