Events

Safety Alert for Lumbar Arthrodesis System ODALYS

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Kisko International S.A.S.

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
    I1404-159
  • Event Number
    2013DM-0010808
  • Date
    2014-04-16
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • 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 in some references and lot specifications of the product, the expiration date specified on the outer packaging is prior to the actual disposal of the device indicated in the internal appendix, this could cause the medical personnel to want to change the device, leading to the presence of wearers in the patient care.

Device

Lumbar Arthrodesis System ODALYS
  • Model / Serial
  • Product Description
    Degenerative spondylolisthesis, stenosis of the spinal canal, vertebral instability (degenerative), fractures, degenerative disc, derivation of a tumor, deformity, degenerative scoliosis, kyphosis, lordosis.
  • Manufacturer
    Kisko International S.A.S

Manufacturer

Kisko International S.A.S