BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 3092531 · Received May 3, 2013

    Report

    Report Number
    0009610622-2013-00238
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NONUNION. GAMMA NAIL REMOVED AND REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193729 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention