Events

Alerta De Seguridad para Osteosynthesis material

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 Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Importacao e Exportacao Ltda.

¿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
    R1708-354
  • Número del evento
    2014DM-0002409-R1 ; 2014DM-0002401-R1 ; 2009DM-0005041
  • Fecha
    2017-10-24
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=67
  • 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
    Invima informs that through ivc's visit it was possible to prove that the referenced product was marketed and implemented without meeting the full requirements of the technical and legal provisions that regulate it, for which the product was withdrawn from the market in a preventive manner, as it is considered a fraudulent product.

Device

Osteosynthesis material
  • Modelo / Serial
  • Descripción del producto
    MDT / BIOTECHNOLOGY joint replacement prostheses are indicated for joint replacement procedures of the shoulder, knee and hip, whether total, partial, modular or revision. Their purpose is to replace the osseous and joint stabilization components for joint function reconstruction in patients with joint damage as a result of pathologies, among others: -non-inflammatory degenerative joint disease (osteoarthritis), -vascular necrosis, -osteoarthritis secondary to trauma, -sequences of trauma, -anquilosis-surgical arthrodesis.
  • Manufacturer
    Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Importacao e Exportacao Ltda

Manufacturer

Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Impor...
  • Source
    NIDFSINVIMA