Events

Alerta De Seguridad para MoPyC Radial Head Prosthesis Stem

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

¿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
    2015-10-14
  • Fecha de publicación del evento
    2015-10-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20151014.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: tornier mopyc radial head prosthesis stem medical device manufacturer, tornier, has issued a field safety notice regarding the radial head prosthesis – mopyc stem – small (catalog number ptr-s7). according to the manufacturer, there is a known risk potentially associated with over-expansion of the affected product that can result in its postoperative fatigue fracture. although the operating technique emphasizes the fact that stem expansion should only be performed when rotation instability is observed in the shaft, the manufacturer noticed that the stems which were subject to fracture were over-expanded. therefore, the manufacturer decided to provide users with a surgical technique addendum (ucmt153) to emphasize this key point of the operating technique and avoid unnecessary stem expansion that may be harmful to the patient. if you are in possession of the products, please contact your supplier for necessary actions. posted on 14 october 2015.

Device

MoPyC Radial Head Prosthesis Stem
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medical Device Safety Alert
  • Manufacturer
    Tornier

Manufacturer

Tornier