Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por Stryker Osteosynthesis Intramedullary Solutions.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 006 04 13 000
  • Fecha de inicio del evento
    2013-04-02
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=3372
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 recall data from the U.S. and Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Stryker received a report indicating that the scale of the axsos calibrated drill bit ø4.3mmx263mm, flat, is incorrect. the scale is used to indicate the correct screw length after the drilling step during surgery, which allows the screw length to be read on the scale and at the end of the drill guide. the incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.

Device

Non-sterile fluted surgical drill, AxSOS Calibrated Drill Bit ø4.3mmx263mm

Manufacturer

Stryker Osteosynthesis Intramedullary Solutions
  • Empresa matriz del fabricante (2017)
    Stryker
  • Representante del fabricante
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA