Events

Safety Alert for System for Use in Procedures of Image Guided Surgery

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Navigation Inc. || Cfi Medical Solutions || Medtronic Navigation, Inc. || Northen Digital Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1705-172
  • Event Number
    2013DM-0010390
  • Date
    2017-05-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that the referenced devices have been rigorously tested and are designed for use only with medtronic instruments, their use with other types of instruments has not been validated or tested, this practice could lead to serious adverse events on the patient.

Device

System for Use in Procedures of Image Guided Surgery
  • Model / Serial
  • Product Description
    Both software and instruments and accessories are for exclusive use with MEDEDONIC's computer-assisted surgery system which is indicated for use in neurosurgery, spinal, orthopedic (hip, knee) and ENT (ear, nose) procedures. and throat). The system allows the exact location of anatomical structures and planning surgical trajectories in open and percutaneous interventions.
  • Manufacturer
    Medtronic Navigation Inc. || Cfi Medical Solutions || Medtronic Navigation, Inc. || Northen Digital Inc

Manufacturer

Medtronic Navigation Inc. || Cfi Medical Solutions || Medtronic Navigation, Inc. || Northen Digit...
  • Source
    NIDFSINVIMA