BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, T10, 3.5X34MM

    MDR report key: 6574400 · Received May 17, 2017

    Report

    Report Number
    0008010177-2017-00105
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    September 14, 2016
    Report Date
    May 17, 2017
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K063875
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. (B)(6) HAS KEPT THE PLATE.

    Description of Event or Problem · 1

    WE WERE FUSING THE NAVICULAR-CUNEIFORM JOINT. INITIALLY PLACED A 4.0 MM SCREW THROUGH THE JOINT THEN USE THE NC PLATE OVER THE TOP. WE PLACED THE PROXIMAL SCREWS ON NAVICULAR THEN WENT TO USE THE COMPRESSION RAP WITH A 3.5 MM NON LOCKING SCREW. AS WE WERE SCREWING IT IN THE HEAD OF THE SCREW FELL COMPLETELY THROUGH THE PLATE. THIS FORCED US TO REMOVE THE CONSTRUCT AND START OVER AGAIN, WEAKENING THE COMPRESSION ACROSS THE ARTHROCLESIS SITE. WE PLACED THE PLATE ON AGAIN AND THEN CLOSED THE CASE. IN POST OP THE DOCTOR NOTICED UNUSUAL MOVEMENT IN THE FOOT AND REALIZED OUR CONSTRUCT HAD FALLEN APART. WE WENT IN AGAIN FOR SURGERY THE NEXT DAY USING A 5.0 INNER FRAG, BIGGER PLATE AND EXTERNAL FIXATION ON TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353636 LOCKING SCREW, T10, 3.5X34MM KAISER HAS KEPT THE PLATE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention