BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL LATERAL FIBULA PLATE, 8 HOLE

    MDR report key: 3592983 · Received January 27, 2014

    Report

    Report Number
    0008010177-2014-00016
    Event Type
    Injury
    Date Received
    January 27, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 7, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    KTT
    PMA / PMN Number
    K081284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, WE WERE MADE AWARE OF A PLATE FAILURE. THE ORIGINAL SURGERY WAS COMPLETED ON (B)(6) 2013 AT (B)(6). PLATE #40-20908 WAS USED AND HAS SINCE FAILED. THE PATIENT ALSO SHOWS INFECTION. THERE IS A REVISION SURGERY SCHEDULED FOR TOMORROW, (B)(6) 2014 AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59505 DISTAL LATERAL FIBULA PLATE, 8 HOLE APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention