Events

Safety Alert for Synthetic bone cement Polybone

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Kyungwon Medical Co, Ltd.

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
    R1706-218
  • Event Number
    2010DM-0006321
  • Date
    2017-06-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=83
  • 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 health agency of brazil has decided to suspend the use, importation, distribution and sale, following the findings made during the international inspection carried out in the facilities of the manufacturer kyungwon medical co., ltd, related to nonconformities of the manufacturing process, leading to their use being presented potential adverse events on users.

Device

Synthetic bone cement Polybone
  • Model / Serial
  • Product Description
    It is a substitute for revolutionary artificial bone that is reabsorbed and replaced by a natural bone to regenerate bone defects in the entire skeletal system. The mechanism of bone formation of POLIBONE, starts with the ingredient polyphosphate, which activates and accelerates bmp bone regeneration. This mechanism allows to achieve better results in the variety of surgeries that involve a bone fracture, a cranial surgery, an oral surgery.
  • Manufacturer
    Kyungwon Medical Co, Ltd

Manufacturer

Kyungwon Medical Co, Ltd
  • Source
    NIDFSINVIMA