BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 4780660 · Received May 19, 2015

    Report

    Report Number
    0008031020-2015-00186
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 20, 2015
    Report Date
    April 20, 2015
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HSN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. UNKNOWN STAR POLY CORE COMPONENT.

    Description of Event or Problem · 1

    PATIENT WENT TO SEE SURGEON AFTER HIS TOTAL ANKLE. PRIMARY SURGEON IMPLANTED THE COMPONENTS IN VARUS AND WAS CAUSING THE PATIENT PAIN. SURGEON TOOK THE IMPLANTS OUT AND FUSED HIS ANKLE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325157 UNKNOWN_SELZACH_PRODUCT IMPLANT HSN STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention