Events

Alerta De Seguridad O Notificaciones De Seguridad para Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por manufacturer #17429.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • ID del evento
    MDA/2007/084
  • Número del evento
    CON2032938
  • Fecha
    2007-11-05
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032938
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Recall due to a manufacturing defect. medtronic is recalling implicated lots of colorado ii locking nuts. according to the manufacturer’s report, two thread grooves are missing on the locking nuts. final tightening may cause the locking nuts to tilt and loosen, causing damage to the thread of the bone screw such that the nuts and the bone screws have to be replaced during the same surgical procedure. the manufacturer has identified that the problem was caused by a manufacturing error and estimates that about 644 potentially affected devices have been distributed in the uk. the manufacturer wrote to users about this recall in september 2007 (see mhra website). the mhra is not aware of any adverse incidents in the uk associated with this problem. medtronic is recalling this implant as a precautionary measure. this alert is being published to facilitate the manufacturer’s recall.
  • Acción
    Do not use affected devices. Quarantine affected devices. Return affected devices to the manufacturer. Report all adverse incidents associated with this device to the manufacturer and the MHRA.

Device

Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system
  • Modelo / Serial
  • Descripción del producto
    Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system. Catalogue number 8634111. Lots: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809 and W07H1810.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429