Events

Alerta De Seguridad para Osteosynthesis Material for Extremities

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 Synthes 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
    R1607-291
  • Número del evento
    2011DM-0007213
  • Fecha
    2016-07-22
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • 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 the batches affected in their yellow guide sheath could have been manufactured with a slightly larger diameter than the specified one, which could prevent the sheath from passing correctly through the brazodirectional tfna, leading to the occurrence of adverse events on patients.

Device

Osteosynthesis Material for Extremities
  • Modelo / Serial
    GUIDE SLEEVE, reference 03.037.017, specific lots.
  • Descripción del producto
    The osteosynthesis material for SYNTHES extremities are nonabsorbable implants designed to help immobilization, stable fixation and stabilization of bone fragments during the treatment of fractures, trauma, reconstruction and bone deformities, restoration of anatomical features and allowing an accurate approximation. There are different types of osteosynthesis implants corresponding to the bones of the extremities of the body, for example: femur, tibia, ulna, radius, humerus, hand, foot, etc. These osteosynthesis implants can be used or not in conjunction with the other osteosynthesis implants to immobilize the affected bone and fix in such a way to induce bone growth and scar healing. The intramedullary nails together with the debloqueo screws are used for the osteosynthesis of big bones like the femur, the tibia and the humerus. SYNTHES deosteosynthesis implants are classified into systems according to their dimensions and shapes that make them more suitable for different parts of the extremities of the body, their traumas and pathologies. It is noted that these implants can be combined with the original parts of the same system.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh