Events

Retiro De Equipo (Recall) de ROTAIO Cervical Disc Prosthesis

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

¿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-01457-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-23
  • 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-01457-1
  • 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
    In the postoperative course patients reported a temporary or permanent development of noise. concerned were approx. 0.12 % of the disc prostheses. in some individual cases the doctors in charge decided to remove the implant. extensive analyses by the manufacturer, signus medizintechnik has not identified any indications as to the causes of the noise development as yet. examinations of implants removed and reference implants performed in that context showed that the prostheses were properly manufactured and fully functional with no structural defects or abnormal signs of wear and tear.
  • Acción
    The manufacturer is adding the possible side effect “temporary or permanent noise development” in the Instructions For Use (IFU).

Device

ROTAIO Cervical Disc Prosthesis

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia