BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALFIX, LOCKING CALCANEAL PLATE, 56MM

    MDR report key: 3683499 · Received March 6, 2014

    Report

    Report Number
    2027754-2014-00001
    Event Type
    Injury
    Date Received
    March 6, 2014
    Date of Event
    January 25, 2012
    Report Date
    March 4, 2014
    Manufacturer
    OSTEOMED
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGERY WAS PERFORMED ON (B)(6) 2011, ON PATIENT'S RIGHT FOOT AND PART # 324-3456 WAS IMPLANTED. ON (B)(6) 2012 DURING PHYSICAL THERAPY LEG PRESS, THE PATIENT FELT SUDDEN ONSET OF PAIN. ON (B)(6) 2012, THE CT SCAN NOTED THAT THE MEDIAL PLATE 324-3456 WAS FRACTURED. ON (B)(6) 2012, SURGERY WAS PERFORMED TO REMOVE THE BROKEN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136117 CALFIX, LOCKING CALCANEAL PLATE, 56MM CALFIX PLATE HRS OSTEOMED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention