Events

Retiro De Equipo (Recall) de SerenoCem Granules BCG050 (Orthopaedic bone cement)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Endotherapeutics 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-2016-RN-00439-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-12
  • 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-2016-RN-00439-1
  • 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
    The manufacturer, corinthian surgical ltd has been made aware of a cluster of cases in the united kingdom where it has been observed that there has been some bone re- absorption in the area adjacent to the granules in the middle ear. this can lead to exposure of the dura and facial nerve, potentially resulting in infection and/or brain herniation. as a precautionary measure corinthian surgical ltd is temporally suspending the supply of serenocem granules and there should be no further use of the granules at this time. the cause of the reported cases of bone resorption is currently under investigation.
  • Acción
    Endotherapeutics is recommending that if a patient presents for a routine checkup or at the 2 yearly follow up, to perform a CT scan. Outside of these circumstances, patients should undergo a CT scan at the clinical discretion of the treating surgeon. Any remaining unused stock should be quarantined and returned to Endotherapeutics. The investigation is currently ongoing, and further communications may be required following completion of the investigation and in consultation with the Therapeutic Goods Administration (TGA).

Device

SerenoCem Granules BCG050 (Orthopaedic bone cement)
  • Modelo / Serial
    SerenoCem Granules BCG050 (Orthopaedic bone cement)All lots affectedARTG Number: 152441
  • Manufacturer
    Endotherapeutics Pty Ltd

Manufacturer

Endotherapeutics Pty Ltd