Alerta De Seguridad para Trade name: Valor®-System Of Ankle Fusion Rods. Technical name: Orthopedic Fixation Systems and Associated Devices. ANVISA registration number: 80491360036. Risk class: III. Model Affected: 415101020R; 415101115R. Serial numbers affected: 1608296; 1610957

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por WRIGHT MEDICAL BRASIL LTDA ME.; Wright Medical Technology, Inc.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    In case of occurrence of adverse events, technical complaints and complaints: contact Wright Medical Brasil through Telephone (11) 3375-6758. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 03/03/2018 - Date of notification notice for Anvisa: 03/23/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012:
  • Causa
    During an internal investigation, wright medical determined for affected valor ™ rod lots, it could be missing the integrated compression screw, which is an accessory component. for this reason, wright medical has decided to initiate this voluntary recall. wright medical has not been notified of post-operative problems or revision surgery related to any of these batches. note: "the company reported that there is only one affected unit of the product.".
  • Acción
    Field Action Code 002/2018 triggered under the responsibility of WRIGHT MEDICAL BRASIL LTDA ME. Gathering