BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, T10, 3.5X24MM

    MDR report key: 6574323 · Received May 17, 2017

    Report

    Report Number
    0008010177-2017-00103
    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 & 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 & EXTERNAL FIXATION ON TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353325 LOCKING SCREW, T10, 3.5X24MM PLATE, FIXATION, BONE HRS STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention