Events

Retiro De Equipo (Recall) de Integra Mayfield Ultra 360 Base Unit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00052-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-20
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00052-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Mayfield ultra 360 base units may experience a failure of the locking system during use due to the excessive clearance between the inner diameter (bore) of the cam rod and the mating post that may potentially result in adverse patient health consequence in the event a breakage occurs during neurosurgical use.No complaint reports have been received in australia or new zealand.
  • Acción
    Customers are to be alerted to this issue and are advised to discontinue use of the device until lntegra verifies their device does not have excessive clearance or if it does, the excessive clearance is corrected. This action has been closed-out on 19/08/2016.

Device

Integra Mayfield Ultra 360 Base Unit

Manufacturer

Integra Neurosciences Pty Ltd