BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 7359570 · Received March 21, 2018

    Report

    Report Number
    3025141-2018-00129
    Event Type
    Injury
    Date Received
    March 21, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ACUMED LLC
    Product Code
    HSB
    PMA / PMN Number
    K915613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS FROM THIS ARTICLE:3025141-2018-00128: CASE 1.

    Description of Event or Problem · 1

    PATIENT WITH FRACTURES OF BOTH THE RADIUS AND ULNA WAS TREATED WITH INTRAMEDULLARY NAILS IN THE RADIUS AND ULNA. THERE WAS ONE SUPERFICIAL INFECTION THAT RESOLVED AFTER THE ADMINISTRATION OF ORAL ANTIBIOTICS. REFERENCE: INTERLOCKING CONTOURED INTRAMEDULLARY NAIL FIXATION FOR SELECTED DIAPHYSEAL FRACTURES OF THE FOREARM IN ADULTS. YOUNG HO LEE, SANG KI LEE, MOON SANG CHUNG, GOO HYUN BAEK, HYUN SIK GONG AND KYUNG HWAN KIM. J BONE JOINT SURG AM. 2008; 90-1891 - 1898.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199841 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention