Events

Retiro De Equipo (Recall) de Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Brainlab 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-2016-RN-01409-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-27
  • 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-01409-1
  • 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
    Brainlab has identified that one part of the femoral and tibial cutting block adapter base was made from incorrect material. consequently, neither biocompatibility nor corrosion resistance of these specific products can be ensured. if corrosion of the femoral and tibial cutting block adapter base occurs and is not detected by the user, and the device is used during surgery, corroded particles could, directly or indirectly, enter the patient’s body and potentially cause tissue irritation or a cytotoxic reaction of the patient. corrosion may also impair successful reprocessing of this device part, so that residue from previous surgeries could adhere to the corroded material. if not detected by the user and the device is used during surgery, germs could be transferred to the patient and lead to infection of the patient. brainlab has not received any reports of such corroded products having been used in surgery, nor of any effects on patients, due to this issue.
  • Acción
    Brainlab is advising users to identify all affected units and remove them from clinical use. They are also advised to dispose them and that they will be provided with a replacement stock. This action has been closed-out on 23/05/2017.

Device

Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base
  • Modelo / Serial
    Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter BaseProduct Number: 41888-04Serial Numbers: ranging from1267114001 to 1267114070 and 1308615032ARTG Number: 121094
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd