Events

Alerta De Seguridad para Ceramic Synthetic Bone Substitute

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 Kasios (Francia) || Nuvasive, Incorporated || Nuvasive Uk Ltd || Iso Tis Orthobiologics, Inc (Estados Unidos) || Progentix - Orthobiology Bv.

¿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
    I1611-546
  • Número del evento
    2015DM-0013550 ; 2010DM-0005553
  • Fecha
    2016-11-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=111
  • 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 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
  • Modelo / Serial
    specific references and lots
  • Descripción del producto
    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