Events

Alerta De Seguridad para Knee prosthesis SCORPIO STRYKER. ALL LOTS. REG. No. 80005430066.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Stryker do 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
    926
  • Fecha
    2008-06-17
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Interference may cause problems during surgery if the surgeon aggressively attempts to progress the cutting block: with pin interference, the pin may bend and hamper or prevent removal of the Cutting Guide, which may result in longer time of surgery, bone lesion or fracture of the distal portion of the femur. The Technovigilance Unit is following up on this case.
  • Causa
    Interference potential between pin and cutting block # 3, used for the preparation of chamfer in knee prosthesis scorpio stryker.
  • Acción
    The company Stryker do Brasil Ltda reported that it has already initiated corrective product action by sending letters to users. In the charts, the user is advised of the risk potential and is instructed to use Correctness Guide No. 3 (X-Celerate Universal Block Pegless size 3, item 8000-3303) to position Cutting Block No. 3 (Universal Notch Preparation Guide size 3, ref. 7650-3363).

Device

Knee prosthesis SCORPIO STRYKER. ALL LOTS. REG. No. 80005430066.

Manufacturer

Stryker do Brasil Ltda
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    ANVSANVISA