BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYAXIAL LOCKING PLATE VARIAX2 NAVICULAR-CUNEIFORM, RIGHT, SHORT (T10)

    MDR report key: 5990390 · Received September 30, 2016

    Report

    Report Number
    0008031020-2016-00493
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 15, 2016
    Manufacturer
    STRYKER GMBH
    Product Code
    HRS
    PMA / PMN Number
    K140376
    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.

    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 ARTHRODESIS 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
    642551 POLYAXIAL LOCKING PLATE VARIAX2 NAVICULAR-CUNEIFORM, RIGHT, SHORT (T10) PLATE, FIXATION, BONE HRS STRYKER GMBH F19946

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention