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 DePuySynthes.

¿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 162 11 13 001
  • Fecha de inicio del evento
    2013-12-01
  • 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=4855
  • 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
    Bending iron tips broke while surgeons were attempting to bend a spinal rod. the majority of complaints involve attempts to bend the warm-worked cobalt chrome (cocr) rods that are part of the matrix system. the failure mode of the tips on the returned field products consisted of a brittle fracture of the proximal tip (i.E. the tip closest to the surgeon). the root cause was determined to be material strength and geometry of the initial design.

Device

Surgical instruments , Bending Iron
  • Modelo / Serial
    Part No : 03.632.040 , Bending Iron for Rods I2J 5.5 mm, left, for Coronal Plane & 03.632.041 Bending Iron for Rods 0 5.5 mm, right, for Coronal Plane. Lot No : T939750 , T939100 , T939750 , T939100 , T952744 , T939755 T939105 , T953987 …………………………………… FDA update code : Part number : ( 03.632.040 ) Lot Numbers : ( 03.632.040 T935338, T945062, T953982, T956310, T959990, T959995 ) Part number : ( 03.632.041 ) Lot Numbers : ( T935343, T939105, T945067, T952750, T956315, T960000, T960005 )
  • Descripción del producto
    Surgical instruments
  • Manufacturer
    DePuySynthes

Manufacturer

DePuySynthes
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Representante del fabricante
    Johnson & Johnson Medical Meddile East
  • Source
    SFDA