Alerta De Seguridad para Drilling Templates 2.7mm LCP

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
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 determined that the screw that connects the fence in the aforementioned templates can be jammed, bent or broken, causing delays in the surgical times or possible adverse events on the patient.


  • Modelo / Serial
    03.111.900, 03.111.901, 03.111.902, 03.111.903,03.111.904 and 03.111.905
  • Descripción del producto
    The osteosynthesis material for SYNTHES® limbs are nonabsorbable implants designed to help the immobilization, stable fixation and stabilization of the osseous 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 healing of the fracture. The intramedullary clamps together with the locking screws are used for osteosynthesis of large bones such as the femur, the tibia and the humerus. SYNTHES® osteosynthesis 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