Events

Safety Alert for Ceramic Synthetic Bone Substitute

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Kasios (Francia) || Nuvasive, Incorporated || Nuvasive Uk Ltd || Iso Tis Orthobiologics, Inc (Estados Unidos) || Progentix - Orthobiology Bv.

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
    I1611-546
  • Event Number
    2015DM-0013550 ; 2010DM-0005553
  • Date
    2016-11-29
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=111
  • 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 it has detected a risk in terms of compliance with the sterilization, which could lead to potential adverse events on the patients.

Device

Ceramic Synthetic Bone Substitute
  • Model / Serial
    specific references and lots
  • Product Description
    Product indicated for the replacement or filling of fissures or bone cavities that are not intrinsic to the stability of the bone structure. It can be used in the treatment of surgical defects or bone defects that are due to traumatic bone injuries. It can be combined with autogenous bone, blood, platelet-rich plasma (PRP for its acronym in English) and / or bone marrow. Product of current-use in surgery of extremities, vertebral column and pelvis. CAGE systems are for use in cervical-anterior arthrodesis to optimize bone fusion. It is used mainly in the following cases: rupture and hernia dedisco; degenerative disc disease; Degenerative instability of the disk.
  • Manufacturer
    Kasios (Francia) || Nuvasive, Incorporated || Nuvasive Uk Ltd || Iso Tis Orthobiologics, Inc (Estados Unidos) || Progentix - Orthobiology Bv

Manufacturer

Kasios (Francia) || Nuvasive, Incorporated || Nuvasive Uk Ltd || Iso Tis Orthobiologics, Inc (Est...
  • Source
    NIDFSINVIMA