BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 7527767 · Received May 18, 2018

    Report

    Report Number
    3025141-2018-00225
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Report Date
    May 8, 2018
    Manufacturer
    ACUMED LLC
    Product Code
    HSB
    PMA / PMN Number
    K951673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2018-00201: CASE 1, 3025141-2018-00202: CASE 2, 3025141-2018-00203: CASE 3, 3025141-2018-00204: CASE 4, 3025141-2018-00205: CASE 5, 3025141-2018-00206: CASE 6, 3025141-2018-00211: CASE 7, 3025141-2018-00212: CASE 8, 3025141-2018-00213: CASE 9, 3025141-2018-00214: CASE 10, 3025141-2018-00215: CASE 11, 3025141-2018-00216: CASE 12, 3025141-2018-00217: CASE 13, 3025141-2018-00220: CASE 14, 3025141-2018-00221: CASE 15, 3025141-2018-00222: CASE 16, 3025141-2018-00224: CASE 17, 3025141-2018-00226: CASE 19, 3025141-2018-00227: CASE 20, 3025141-2018-00228: CASE 21.

    Description of Event or Problem · 1

    PATIENT WITH A FRACTURE OF THE FIBULA WAS TREATED WITH A FIBULA ROD AND TWO SCREWS. THE CONSTRUCT FAILED BUT DID NOT REQUIRE REVISION SURGERY. REFERENCE: BUGLER, K.E., ET AL., THE TREATMENT OF UNSTABLE FRACTURES OF THE ANKLE USING THE ACUMED FIBULAR NAIL: DEVELOPMENT OF A TECHNIQUE. J BONE JOINT SURG BR, 2012. 94(8): P. 1107-12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368155 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1