Events

Alerta De Seguridad para Prosthesis for Joint Replacement

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
    R1703-96
  • Número del evento
    2014DM-0002401-R1
  • Fecha
    2017-03-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • 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 has determined that in the referenced devices there is a possible deviation of the measures according to the technical specifications, leading to the occurrence of possible adverse events on the patient or delays in the procedure.

Device

Prosthesis for Joint Replacement
  • Modelo / Serial
  • Descripción del producto
    The MDT / BIOTECHNOLOGY joint replacement prostheses are indicated for joint, shoulder, knee and hip joint replacement procedures, whether total, partial, modular or revision. Their purpose is to replace bone and joint stabilization components for the reconstruction of joint function in patients with joint injuries as a result of pathologies, among others: non-inflammatory degenerative joint disease (osteoarthritis), avascular 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