Events

Alerta De Seguridad para KYPHON and KYPHON EXPRESS Directional Bone Void Filler

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

¿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
    2017-05-15
  • Fecha de publicación del evento
    2017-05-15
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170515b.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 kyphon and kyphon express directional bone void filler medical device manufacturer, medtronic, has issued a medical device safety alert concerning its kyphon and kyphon express directional bone void filler. [product number: f04c, all lot numbers affected]. the manufacturer has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut-out opening on the distal end of the instrument. using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon. possible risks associated with this misalignment include cement extravasation into the spinal canal with a potential result of paralysis or nerve injury with risk of pulmonary embolism or cardiac arrest. the manufacturer has received two reports of this misalignment. to date there have been no associated patient injuries resulting from this issue. affected users are advised to locate and remove the impacted product from normal storage locations. they should discontinue use of the affected product and contact the manufacturer for recall and replacement. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2017.

Device

KYPHON and KYPHON EXPRESS Directional Bone Void Filler
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic KYPHON and KYPHON EXPRESS Directional Bone Void Filler
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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