BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL

    MDR report key: 9251501 · Received October 29, 2019

    Report

    Report Number
    3025141-2019-00448
    Event Type
    Injury
    Date Received
    October 29, 2019
    Report Date
    October 10, 2019
    Manufacturer
    ACUMEDLLC
    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: 3025141-2019-00442: CASE 1, 3025141-2019-00443: CASE 2, 3025141-2019-00444: CASE 3, 3025141-2019-00445: CASE 4, 3025141-2019-00446: CASE 5, 3025141-2019-00447: CASE 6, 3025141-2019-00449: CASE 8.

    Description of Event or Problem · 1

    ARTICLE: SURGICAL TREATMENT OF DISPLACED PROXIMAL HUMERUS FRACTURES WITH A SHORT INTRAMEDULLARY NAIL, NOLAN, BETSY M. MD; KIPPE, MATTHEW A., MD; WIATER, MICHAEL, MD; NOWINSKI, GREGORY P., MD; J SHOULDER ELBOW SURG (2011) 20, 1241-1247. CASE 7: PATIENT UNDERWENT REVISION SURGERY TO REMOVE POLARUS HARDWARE DUE TO LOSS OF FIXATION OR PROMINENT HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047785 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL LXH ACUMEDLLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention