BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T25 LOCKING SCREWS

    MDR report key: 3042076 · Received April 5, 2013

    Report

    Report Number
    3042076
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    February 21, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO LOCKING SCREWS BROKE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ORIF RIGHT TIBIA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141257 T25 LOCKING SCREWS SCREW, FIXATION, BONE HWC SYNTHES (USA) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR