Events

Alerta De Seguridad para System for Articular Prostheses for Elbow rHead Radial Head

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 Small Bone Innovations Internacional.

¿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
    R1712-570
  • Número del evento
    2010DM-0005229
  • Fecha
    2017-12-19
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=62
  • 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 as a result of a review of the data currently available from the referenced devices found that it was not conclusive to continue supporting the performance of the device, consequently decided to withdraw the product from global markets, health professionals who have implanted patients should continue monitoring according to the protocol of usual attention, since the described situation could lead to the occurrence of adverse events on patients.

Device

System for Articular Prostheses for Elbow rHead Radial Head
  • Modelo / Serial
    RCNH2, RCNH3, RCNH4, RCNS1, RCNS160, RCNS2, RCNS260
  • Descripción del producto
    To replace the head of the radio when there is degeneration due to arthritis or post-traumatic disability that presents pain, crepitus and decreased mobility in the radio-humeral bone or cubitoproximal radius, joint friction with articular destruction or subluxation visible on radiography and resistance to preservation of treatment for arthritis.
  • Manufacturer
    Small Bone Innovations Internacional

Manufacturer

Small Bone Innovations Internacional
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NIDFSINVIMA