Alerta De Seguridad para Hygiene Technical Name: Modular System for Arthroplasty Total ANVISA Registration Number: 10417940085 Hazard Class: III Model Affected: Acetabular Insert PHENOM Poly (04.13.13.xxxxx) / Acetabular Insert PHENOM Poly Rear Ceiling (04.13.14.xxxxx)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importação e Exportação de Implantes S.A..

¿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 MDT company and / or to customers outside Brazil, they should carry out the disposal in loco as indicated by the IU We recommend to users and patients that there are some technical complaints and adverse events involving the products mentioned in the Field Action (which can be verified on the Traceability Labels sent to each product), the Distributor and the MDT Manufacturer and / or the NOTIVISA System must be reported. To the users, it is confirmed that clinical follow-up of patients already implanted is not necessary, since possible failures are perceptible during the implantation procedure, making it possible to substitute the product and not causing a serious adverse event to the patient.
  • Causa
    In order to reduce the risks associated with the possibility of a break in the fin or impossibility of impaction of the insert due to the improper positioning of the insert in the acetabulum, the mdt company voluntarily initiated this field action for the collection of all existing products in the market, as well as , scrapping items in their own stock.
  • Acción
    Field Action Code AC201601 triggered under the responsibility of the company MDT Industria Comércio Importacao e Exportação de Implantes SA Company will make collection.