BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUB CAP® WRIST FUSION PLATE

    MDR report key: 8566297 · Received April 30, 2019

    Report

    Report Number
    3025141-2019-00224
    Event Type
    Injury
    Date Received
    April 30, 2019
    Report Date
    April 9, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K021321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00225: PLATE 2, 3025141-2019-00226: PLATE 3, 3025141-2019-00227: PLATE 4.

    Description of Event or Problem · 1

    ARTICLE: OUTCOMES OF FOUR-CORNER ARTHRODESIS USING THE HUBCAP TM CIRCULAR PLATE. KHAN, SAMEER K., ALI, SYED M., MCKEE, ANDREW, JONES, JONATHAN W. M. HAND SURGERY, VOL. 18, NO. 2 (2013) 215-220. CASE 1: SUPERFICIAL WOUND INFECTION; TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359046 HUB CAP® WRIST FUSION PLATE PLATE, FIXATION, BONE HRS ACUMED LLC PL-WF40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention