Events

Retiro De Equipo (Recall) de NAJA Spinal Ligament Systems for Spinal Stabilization

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Evolution Surgical 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-00007-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-10
  • 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-00007-1
  • 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, cousin biotech, through post-market surveillance systems has identified three successive cases of breakage of the metal connector clamping system that occurred during surgery. for these three incidents, there were no serious clinical outcomes for patients except a slight increase in operating time to use another medical device.
  • Acción
    1. The letter should be passed on to end-users, to all persons concerned in your company, or to any other organization (healthcare centers) to which potentially affected products have been sent. 2. Check stock and quarantine all unused devices with the batch numbers identified. 3. Complete the supplied form and return it to the email address provided for the sponsor to arrange the collection of affected units.

Device

NAJA Spinal Ligament Systems for Spinal Stabilization
  • Modelo / Serial
    NAJA Spinal Ligament Systems for Spinal StabilizationReference Numbers: RCBNAJ55LU, RCBNAJ55RUBatch Numbers - 141527, 141724, 141896, 151605, 151940, 151939, 152079, 152319, 171823, 170696, 172044, 151604, 152080ARTG Number: 273278 (Evolution Surgical Pty Ltd - Spinal internal fixation system, intervertebral body)
  • Manufacturer
    Evolution Surgical Pty Ltd

Manufacturer

Evolution Surgical Pty Ltd
  • Source
    DHTGA