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 Changzhou Hengjie Medical Devices 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
    R1703-84
  • Número del evento
    2011DM-0008305
  • Fecha
    2017-03-01
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=99
  • 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 states that it has detected the possibility of displacement of the screw that makes up the dhs system in the head of the femur, apparently due to a manufacturing defect in the sliding screw, observing that the marked limit of displacement is lower compared to others of the same measure, leading to to delays in the procedure opposing adverse events on the patient.

Device

Osteosynthesis Material
  • Modelo / Serial
  • Descripción del producto
    Treatment of traumas and / or pathologies that compromise the appendicular skeleton. Treatment of fractures in the lower and upper limbs. Repair of bones and fractures in general, temporarily or definitively of the appendicular skeleton. Fixation of bone fragments and osteotomies. Orthopedic surgery. The surgical instrument is for exclusive use and is used to help alensamble / disassembly, implantation and removal of the implant.
  • Manufacturer
    Changzhou Hengjie Medical Devices Co.Ltd.

Manufacturer

Changzhou Hengjie Medical Devices Co.Ltd.