Alerta De Seguridad para Technical Name: Non-absorbable tubular angled plate for osteosynthesis ANVISA Registration Number: 80034760050 Hazard Class: III Model Affected: 2266-318-095 Serial Numbers Affected: 00107967/006939 - 08 units - Date of manufacture: 01/14/2016 00109330/006939 - 08 units - Date of manufacture: 01/14/2016 00107963/006939 - 11 units - Date of manufacture: 01/14/2016 00110188/006939 - 11 units - Date of manufacture: 01/14/2016 00107966/006939 - 04 units - Date of manufacture: 01/14/2016

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Meta Bio Industrial Ltda.; Meta Bio Industrial 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
  • 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
    Non-deployed products should be segregated and returned to the company Meta Bio, which is discontinuing the plates above 16 holes, due to low commercialization and the need to use a product with this extension. We recommend to users and patients that, if there is any type of technical complaint and adverse event involving the products mentioned in this Field Action, it must be reported to the Distributor and / or to the Meta Bio Manufacturer and / or through the NOTIVISA System. To the users, it is confirmed that it is not necessary the clinical follow-up of patients already implanted, since it is an implant with temporary function, that is, it is destined to stabilization and fixation of the fracture until osseointegration occurs, past this period the implant loses its function.
  • Causa
    18-hole plate made with 295 mm in length, in disagreement with the 18-hole plate which, in the description and registration of the product, specifies a length of 279 mm.
  • Acción
    Field Action Code Tube Plate - 2017 triggered under the responsibility of the company Meta Bio Industrial Ltda. Company will make collection for later return to the manufacturer.