Events

Alerta De Seguridad para Synthetic bone cement Polybone

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Kyungwon Medical Co, Ltd.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    R1706-218
  • Número del evento
    2010DM-0006321
  • Fecha
    2017-06-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=83
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    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