Events

Retiro De Equipo (Recall) de Medtronic Spinous Process Clamps

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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-2017-RN-00864-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-07-18
  • 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-2017-RN-00864-1
  • 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
    Medtronic has become aware of instances where spine clamps have been damaged when forced open beyond their intended limits during use and will subsequently not open once attached to a patient’s spinous process. when the spine clamp is forced open beyond its intended limits, a component (captive washer) may break off. the washer could then be inadvertently left behind in a patient’s body if the breakage occurs during the procedure. if the washer is missing from the device, the spine clamp cannot be re-opened after placement on the spinous process.Medtronic has received six reports where unintended removal of spinous process occurred when attempting to detach the spine clamp. the unintended removal of spinous process can lead to damage of adjacent vertebra and cause premature degradation.
  • Acción
    Medtronic is providing an interim workaround for users via the Customer Letter. A new version of the clamps with a design mitigation will be distributed as a permanent correction once available.

Device

Medtronic Spinous Process Clamps
  • Modelo / Serial
    Medtronic Spinous Process ClampsSpine Referencing InstrumentationModel/Catalogue Numbers9734715 Spinous Process Clamp, Tall9734716 Spinous Process Clamp, Short9734723 Double Spinous Process Clamp, Tall9734724 Double Spinous Process Clamp, Short 9734715K Spinous Process Clamp, Tall9734716K Spinous Process Clamp, Short9734723K Double Spinous Process Clamp, Tall9734724K Double Spinous Process Clamp, Short9735500 Set (contains 9734715 & 9734716)ARTG Number: 125074
  • Clasificación del producto
    Orthopedic Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA