Events

Alerta De Seguridad para Implant Systems for Traumatology

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 Stryker Gmbh.

¿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
    I1705-171
  • Número del evento
    2013DM-0010034
  • Fecha
    2017-05-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • 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 the device is not completely cannulated and the guidewire will not be able to pass through it, this obstruction is related to a metal drill in the screw cannula that has not been eliminated during fabrication, this could lead to the occurrence adverse adverse events in surgical times.

Device

Implant Systems for Traumatology
  • Modelo / Serial
  • Descripción del producto
    This device is used to stabilize open or unstable fractures and where soft tissue damage causes other fracture treatments such as IM bars, metal parts and other internal fixation means to be discarded. The indications for the fixation devices include: fixation of bone fractures, osteotomy, arthrodesis, correction of deformities, revision procedures when other treatments and devices, bone reconstruction procedures have failed.
  • Manufacturer
    Stryker Gmbh

Manufacturer

Stryker Gmbh
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NIDFSINVIMA