BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL

    MDR report key: 9241792 · Received October 25, 2019

    Report

    Report Number
    3025141-2019-00416
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CASES ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00414: CASE 1, 3025141-2019-00415: CASE 2, 3025141-2019-00417: CASE 4.

    Description of Event or Problem · 1

    ARTICLE: TREATMENT OF PROXIMAL HUMERAL FRACTURES WITH POLARUS NAIL FIXATION NAIL, AGEL, JULIE, MA; JONES, CLIFFORD B, MD; SANZONE, ANTHONY G., MD; CAMUSO, MATTHEW, MD; HENLEY, M. BRADFORD, MD; JOURNAL OF SHOULDER AND ELBOW SURGERY, 2004, VOLUME 13, NUMBER 2, 191-195. CASE 3: IN PATIENT, THE POLARUS NAIL WAS INSERTED THROUGH THE GREATER TUBEROSITY FRACTURE AND LATERAL TO THE SULCUS; NAIL FAILED BUT HEALED WITH VARUS COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037371 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL LXH ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1