Events

Alerta De Seguridad para Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic Limited.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-09-04
  • Fecha de publicación del evento
    2012-09-04
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120904.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic screw module used with the atlantis and premier anterior cervical plate system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning the recall of the screw module ("screw caddy") used with the atlantis anterior cervical plate system and the premier anterior cervical plate system, (part numbers176-504, 176-503, and 1860503), manufactured by medtronic limited. medtronic has discovered that the measurement gauge located on the lower corner of the caddy may be out of specification, which could cause a screw to be measured improperly. an incorrect gauge could measure a screw to be approximately 1mm shorter than its actual length. no patient injuries have been reported to date. however, using an inappropriately long screw could cause irreversible neurologic injury if it penetrated the vertebral body. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 4 september 2012.

Device

Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System
  • Manufacturer
    Medtronic Limited

Manufacturer

Medtronic Limited
  • 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
    DH