BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL NAIL, STANDARD T2 TIBIA Ø11X360 MM

    MDR report key: 3940095 · Received July 17, 2014

    Report

    Report Number
    0009610622-2014-00343
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    October 18, 2012
    Report Date
    June 27, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K003018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT SUFFERED FRACTURE TO BOTH TIBIA AND FIBULA ON (B)(6) 2012. ON (B)(6) 2012 PATIENT UNDERWENT SURGERY AT (B)(6) HOSPITAL WITH STRYKER PRODUCTS. FOLLOWING THE PRESENTATION OF COMPLICATIONS, PATIENT SUFFERED AN INFECTION FOLLOWING ONE OF THESE SURGERIES. FURTHER SURGERY WAS UNDERTAKEN ON (B)(6) 2012. SURGEON ALLEGED THAT ONE OF THE TWO DISTAL SCREWS OF THE INTRAMEDULLARY NAIL WERE BROKEN IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418560 TIBIAL NAIL, STANDARD T2 TIBIA Ø11X360 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K173240

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention