Alerta De Seguridad O Notificaciones De Seguridad para CALAXO interference screw implants

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 Smith & Nephew Inc.

¿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/2007/076
  • Número del evento
    CON2032595
  • Fecha
    2007-10-04
  • País del evento
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
  • 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 pre-tibial soft tissue swelling after implantation of calaxo screws leading to the need for surgical intervention to remove any remaining screw fragments.
  • Acción
    Identify and quarantine any unimplanted affected devices. Do not implant affected devices. Return affected devices to the manufacturer. Identify and quarantine any unimplanted affected devices. Do not implant affected devices. Return affected devices to the manufacturer. Identify all patients implanted with this screw. If they present with pre-tibial swelling within 2-36 weeks of implantation, consider: aspirating the area for routine cultures local debridement and removal of any remaining screw fragments replacement with an alternative screw or bone graft if necessary. Report all adverse incidents related to CALAXO screws to the implant manufacturer and the MHRA.

Device

  • Modelo / Serial
  • Descripción del producto
    Bioresorbable screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc. All lot numbers and all item codes distributed since 2006. Smith & Nephew Inc. is recalling all lot numbers and all item codes of CALAXO screws which were first distributed in the UK in 2006. This screw is used to secure the graft in anterior cruciate ligament (ACL) reconstruction. Worldwide, 0.3% of patients have developed pre-tibial soft tissue swelling, which can mimic the appearance of an infection between 2 and 36 weeks after implantation. The manufacturer is currently investigating the cause of this problem. Most cases resolved without intervention. A small number of cases needed local debridement and removal of any remaining screw fragments, or replacement with an alternative screw or bone graft. The manufacturer estimates that about 2,550 devices have been used in the UK since 2006. The manufacturer is aware of seven reported cases of inflammation in the UK of which two required implant revision. The manufacturer wrote to chief executive officers of trusts, theatre managers, and surgeons who were known to use CALAXO about this product recall in August 2007 (see MHRA website). This notice is to facilitate the recall.
  • Manufacturer

Manufacturer