BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES (USA)

    MDR report key: 789998 · Received November 28, 2006

    Report

    Report Number
    789998
    Event Type
    Injury
    Date Received
    November 28, 2006
    Date of Event
    November 10, 2006
    Report Date
    November 27, 2006
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING RENEWED SYMPTOMS. X-RAY SHOWED HARWARE BROKEN. SURGEON TOOK PATIENT BACK TO SURGERY TO REMOVE THE BROKEN HARD-WARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES (USA) SCREW HEAD FOR TI CLICK 3-D HWC SYNTHES USA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention