Alerta De Seguridad para INTRAMEDULAR STEMS WITH ISKD - ORTHOFIX KINETIC DISTRACTION. Registro Anvisa n ° 10392060017 .. Products Affected :. . Femoral stems. Catalog Description. F12-255-305 12.5 diameter, range 255 mm - 305 mm ;. F12-255-335 12.5 diameter, range 255 mm - 335 mm ;. F12-300-350 12.5 diameter, range 300 mm - 350 mm ;. F12-300-380 12.5 diameter, range 300 mm - 380 mm ;. F12-345-395 12.5 diameter, range 345 mm - 395 mm ;. F12-345-425 12.5 diameter, range 345 mm - 425 mm. Tibial stems. Catalog Description. T10-215-265 10.7 diameter, range 215 mm - 265 mm ;. T10-255-305 10.7 diameter, range 255 mm - 305 mm ;. T10-255-335 10.7 diameter, range 255 mm - 235 mm ;. T10-300-350 10.7 diameter, range 300 mm - 350 mm ;. T12-215-265 12.5 diameter, range 215 mm - 265 mm ;. T12-245-295 12.5 diameter, strip 245 min - 295 mm ;. T12-255-305 12.5 diameter, range 255 mm - 305 mm ;. T12-255-335 12.5 diameter, range 255 mm - 335 mm ;. T12-300-350 12.5 diameter, range 300 mm - 350 mm ;. T12-300-380 12.5 diameter, range 300 mm - 380 mm.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Orthofix Brasil Ltda..

¿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
    1168
  • Fecha
    2012-08-27
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The ISKD Rod is formed of a body embedded in the other, containing a magnet inside it that functions as a reference sensor for reading, done externally through the Manual Monitor accessory (FTM code 222) that the doctor and patient use periodically to monitor progress of the extension. The extension is produced by small movements in the form of small rotational oscillations of the limb under treatment - with these movements, the mechanism within the shaft gradually produces distraction of the limb. The extent index can vary by changing the level of activity of the patient or by manipulating the extremity. Through measurements, both the physician and the patient can regularly monitor the level of extent achieved. With the problem mentioned in this alert, the product may stop distracting in the postoperative period during treatment, resulting in premature bone healing (limb does not reach the desired length) - which can lead to revision surgery to remove or replace the device.
  • Causa
    The rod extender mechanism may be defective and not distract the expected length, or even distract.
  • Acción
    The company has already started collecting the product. If you have affected products in your stock, segregate them to avoid inadvertent use, and contact the company to verify the procedures for returning the products.

Manufacturer