Events

Safety Alert for titanium alloy metal implants

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

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
    R1511-510
  • Event Number
    2013DM-0010808
  • Date
    2015-11-05
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=167
  • 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 indicates that it has been able to detect that the referenced medical devices may have compromised their sterility, leading to possible adverse events due to contamination on the patients.

Device

titanium alloy metal implants
  • Model / Serial
    ODALYS / 10MS0160, 10MS0170, 10MS0180, 10PS0020, 10PS0030, 10PS0040, 10PS0070, 10PS0110, 10PS0120, || 10PS0130 and 10SS0070, specific lots
  • Product Description
    1. Degenerative spondylolisthesis, 2. Stenosis of the vertebral canal, 3. Vertebral instability (degenerative), 4. Fractures, 5. Degenerative disc, 6. Derivation of a tumor, 7. Spinal deformity (degenerative scoliosis, kyphosis, lordosis)
  • Manufacturer
    Kisko International SAS

Manufacturer

Kisko International SAS