Events

Retiro De Equipo (Recall) de Custom Made Implant Systems with Minimally Invasive Grower (MIG) component

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia 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-2018-RN-00083-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-30
  • 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-2018-RN-00083-1
  • 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 march 2007 the minimum invasive grower (mig) component with locking mechanism was utilised with custom made long bone replacement implants for limb salvage procedures of skeletally immature or juvenile patients, to prevent unintended changes in the length of the device. the instructions for use (ifu) for these types of devices did not clarify the function of the locking mechanism and the warnings related to the locking screw until october 2014, resulting in potential lack of awareness of the locking mechanism and its function during that time.The omission of this information in the ifu has been identified as a potential risk in risk management files for custom made devices, with the potential effects including; prolonged surgery, instability, pain, impaired function (gait) and early revision. limb length discrepancy was also identified as a potential effect based on complaints data review.
  • Acción
    Patients implanted with an affected lot number of the Custom Implants with MIG component should continue to be followed per the normal protocol established by his/her surgeon.

Device

Custom Made Implant Systems with Minimally Invasive Grower (MIG) component
  • Modelo / Serial
    Custom Made Implant Systems with Minimally Invasive Grower (MIG) componentComponents implanted prior to October 2014Item Numbers: 13271, 14092, 14205, 15757, 16782, 17944These items are custom made to the patients ID and exempt from ARTG Numbers
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA