Events

Alerta De Seguridad para Dynamic Locking Screw Stardrive

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

¿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
    2013-06-14
  • Fecha de publicación del evento
    2013-06-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130614b.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: synthes dynamic locking screw stardrive medical device manufacturer, synthes, has issued a medical device safety alert concerning certain lots of the dynamic locking screw stardrive ø 3.7mm, self-tapping, cobalt-chrome alloy (cocrmo), sterile [length 22mm to 70mm] and ø 5.0 mm, self-tapping, cobalt-chrome alloy (cocrmo),sterile [length 32mm to 90mm]. the manufacturer received several complaints and investigations showed breakage at the bottom of the pin of the dynamic locking screw (dls). the breakages are recognized during planned implant removal of the whole construct after successful healing. there is the potential that the breakage of a dls may result in a mal-union or non-union requiring additional medical intervention. in a worst case scenario there is the potential for permanent impairment to occur in the presence of a mal-union or non-union. serious injury described as soft tissue damage/irritation and prolonged surgical procedures have been reported as a result of dls breakage. however, no known events of permanent impairment have been reported due to the breakage of a dls. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2013.

Device

Dynamic Locking Screw Stardrive
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Synthes Dynamic Locking Screw Stardrive
  • Manufacturer
    Synthes

Manufacturer

Synthes