BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 7527785 · Received May 18, 2018

    Report

    Report Number
    3025141-2018-00235
    Event Type
    Injury
    Date Received
    May 18, 2018
    Report Date
    May 8, 2018
    Manufacturer
    ACUMED LLC
    Product Code
    HSB
    PMA / PMN Number
    K951673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS ARTICLE: 3025141-2018-00231: CASE 1; 3025141-2018-00233: CASE 2.

    Description of Event or Problem · 1

    PATIENT WITH A FRACTURE OF THE FIBULA WAS TREATED WITH A FIBULA ROD AND SCREWS. THE PATIENT HAD SUBLUXATION OF THE ANKLE JOINT POSTERIORLY, AFTER A TRI-MALLELOAR FRACTURE WAS FIXED WITH A NAIL. THE POSTERIOR FRACTURE WAS INITIALLY HELD WITH 2 SMALL FRAGMENT CANCELLOUS SCREWS. REVISION OF THE FIXATION WAS UNDERTAKEN USING A POSTERIOR PLATE ON THE TIBIA IN ADDITION TO A POSTERIOR FIBULA PLATE. THE PATIENT DEVELOPED A LATERAL INFECTION AND AGAIN LOST FIXATION, EVENTUALLY REQUIRING AN ANKLE FUSION. THE PATIENT HAD SIGNIFICANT COMORBIDITIES PREOPERATIVELY, INCLUDING CHRONIC STEROID USE. REFERENCE: APPLETON, P ET AL., THE FIBULA NAIL FOR TREATMENT OF ANKLE FRACTURES IN ELDERLY AND HIGH RISK PATIENTS. TECHNIQUES IN FOOT AND ANKLE SURGERY 5(3):204-208, 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370396 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention