Events

Retiro De Equipo (Recall) de INFUSE/LT Cage Bone Graft Kit (Used for spinal fusion procedures)

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-2013-RN-00563-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-06-13
  • 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-2013-RN-00563-1
  • 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
    Multiple lots of infuse/lt cage bone graft kit is affected due to an issue with absorbable collagen sponge (acs) which is a component of the infuse/lt cage bone graft kit. the component supplier, integra lifesciences corporation has advised medtronic that a manufacturing process deviation may have resulted in some lots of absorbable collagen sponge being released and supplied to medtronic with higher levels of endotoxins than permitted by the specifications for the products. higher endotoxin levels may result in a fever in the immediate postoperative period. medtronic are not aware of any reports of patient injuries or other adverse events in connection with this issue.
  • Acción
    Medtronic is recalling the affected product and is asking clinicians through the 'hazard alert' to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol. For more details, please see http://www.tga.gov.au/safety/alerts-device-infuse-130627.htm .

Device

INFUSE/LT Cage Bone Graft Kit (Used for spinal fusion procedures)
  • Modelo / Serial
    INFUSE/LT Cage Bone Graft Kit (Used for spinal fusion procedures)Catalogue Numbers 7510200AUS / SMALL, 7510400AUS / MEDIUM, 7510800AUS / LARGELot Numbers: M111052AAM, M111052AAT, M111054AAR, M111059AAE, M111063AAE, M111063AAF, M111063AAK, M111063AAO, M111064AAH, M111064AAN, M111103AACARTG 121164
  • 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