Events

Alerta De Seguridad para EXACTECH Joints Replacement Prosthesis System

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 Exactech Inc.

¿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
    I1706-215
  • Número del evento
    2012DM-0001331-R1
  • Fecha
    2017-06-09
  • 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 manufacturer reports that it has updated the surgical technique for the implantation of the hip system, clarifying the proper technique for the use of the calcar planar guide tip, including precautions to avoid fracture of the instrument, leading to a reduction in the probability of presenting adverse events on patients. .

Device

EXACTECH Joints Replacement Prosthesis System
  • Modelo / Serial
  • Descripción del producto
    Indicated in skeletally mature individuals undergoing primary surgery for joint replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems and for fracture treatment, among others. They are also indicated for review of defective anterior reconstructions, where there is sufficient bone density and soft tissue integrity.
  • Manufacturer
    Exactech Inc

Manufacturer

Exactech Inc
  • Empresa matriz del fabricante (2017)
    Exactech Inc
  • Source
    NIDFSINVIMA