BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® LAG SCREW

    MDR report key: 3672558 · Received March 11, 2014

    Report

    Report Number
    2520274-2014-10197
    Event Type
    Injury
    Date Received
    March 11, 2014
    Report Date
    February 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. COMMON DEVICE NAME: ADDITIONAL PRODUCT CODE JDO. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    A REMOVAL OF THE DYNAMIC HIP AND CONDYLAR SCREW (DHS) PLATE, LAG SCREWS, AND 12.5MM CORTEX SCREWS DUE TO THE NON-UNION PROXIMAL FEMUR WAS REPORTED. THE DHS PLATE WAS INTACT. THERE WERE ELEVEN (11) 4.5MM BROKEN SCREWS. THE BROKEN SCREWS WERE LEFT INSIDE THE PATIENT. THE PATIENT WAS REVISED WITH 4.5MM LOCKING COMPRESSION PLATE (LCP) PROXIMAL FEMUR PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144122 DHS®/DCS® LAG SCREW APPLIANCE, FIXATION, NAIL/BLADE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention