BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORTEX SCREW

    MDR report key: 567568 · Received January 20, 2005

    Report

    Report Number
    567568
    Event Type
    Other
    Date Received
    January 20, 2005
    Date of Event
    January 3, 2005
    Report Date
    January 19, 2005
    Manufacturer
    SYNTHES USA, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    A SCREW BROKE OFF IN THE PATIENT. SURGEON WAS ABLE TO RETRIEVE THE SCREW AND THE BROKEN PIECE WITHOUT ANY SIGNIFICANT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTEX SCREW ORTHOPEDIC SCREW HWC SYNTHES USA, INC. 401.830.96 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR NONE KNOWN.