BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL

    MDR report key: 9241774 · Received October 25, 2019

    Report

    Report Number
    3025141-2019-00410
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ACUMED LLC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CASES ASSOCIATED WITH THIS ARTICLE: 3025141-2019-00404: CASE 1, 3025141-2019-00405: CASE 2, 3025141-2019-00406: CASE 3, 3025141-2019-00407: CASE 4, 3025141-2019-00408: CASE 5, 3025141-2019-00409: CASE 6.

    Description of Event or Problem · 1

    ARTICLE: THE RESULTS OF INTERNAL FIXATION OF THREE- AND FOUR-PART PROXIMAL HUMERAL FRACTURES WITH THE POLARUS NAIL, ADEDAPO, A.O., IKPEME, J.O.; INJURY: INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED 32 (2001) 115-121. CASE 7: A POLARUS NAIL WAS IMPLANTED. PATIENT HAD AVASCULAR NECROSIS AND COLLAPSE OF THE HUMERAL HEAD THAT LED TO NAIL PROTRUSION AND SUB-ACROMIAL IMPINGEMENT; THE ENTIRE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032376 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL LXH ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention