BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 7359569 · Received March 21, 2018

    Report

    Report Number
    3025141-2018-00128
    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: 3025141-2018-00129: CASE 2.

    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 NONUNION OF THE ULNA. THE NAIL WAS REMOVED, A PLATE WAS APPLIED (SUPPLEMENTED WITH AN AUTOLOGOUS ILIAC CREST BONE GRAFT) AND UNION WAS ACHIEVED. THE PATIENT WAS NON-COMPLIANT AS HE PREMATURELY REMOVED THE CAST (WHICH WAS SUPPOSED TO REMAIN IN PLACE FOR FOUR WEEKS FOLLOWING SURGERY). ADDITIONALLY, THE NAIL THAT WAS USED WAS 1CM LONGER THAN OPTIMUM SIZE. 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
    199842 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention