Alerta De Seguridad O Notificaciones De Seguridad para Implantable screw

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 Synthes GmbH.

¿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
  • Número del evento
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • 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
    Recall due to incorrectly etched screw size on the screw-holding clip (see picture).The use of an incorrectly sized screw could lead to clinical complications including dural injury, bleeding and failure of fracture fixation.The manufacturer has received reports of instances where the number etched on the screw holder does not match the length of the screw. This includes screws being labelled as being longer or shorter than they actually are. However, the outer packaging of the device has the correct screw size.The use of an incorrectly sized MatrixMANDIBLE, MatrixMlDFACE and MatrixORTHOGNATHlCS screw could lead to inadequate fixation or loss of fixation.The use of an incorrectly sized MatrixNEURO screw may result in a life threatening event for patients at greatest risk. If the screw is too long, the greatest risks are posed to paediatric patients, patients with skull deformities, and patients with face lesions because they are predisposed to having skulls that may not be as thick as the largest available screw (5mm). If a screw is longer than anticipated it may come into contact with the patient’s dura and small vessels.The manufacturer has recalled these devices and will be offering an alternative.
  • Causa
    (synthes gmbh) could lead to clinical complications including dural injury, bleeding and failure of fracture fixation. (mda/2013/044).
  • Acción
    Identify and quarantine any unimplanted affected devices using the list of lot numbers in the manufacturer’s Field Safety Notice (FSN) Return unused affected devices to the manufacturer. If there are no alternatives and you need to use the affected screws you should confirm the length of the screw prior to use by measuring it on the measuring scale provided on the case.The manufacturer advises that patients who have had procedures using the Synthes CMF Matrix Screws should be followed up using standard diagnostic evaluation and treatment protocols. If the follow-up reveals risk to vessels or dura, the potential for inadequate fixation or potential loss of fixation due to incorrect screw length, standard diagnostic evaluation and treatment protocols for these types of events should be followed.


  • Modelo / Serial
  • Descripción del producto
    Implantable screw: MatrixMANDIBLE, MatrixNEURO, MatrixMlDFACE and MatrixORTHOGNATHlCS.Manufactured by Synthes GmbH.Specific lot numbers affected.The affected screws were first distributed in July 2007.  Each screw is held within a clip that has a number etched on it, corresponding to the length of the screw.
  • Manufacturer


  • Dirección del fabricante
    Synthes GmbH Luzernstrasse 21 CH-4528 Zuchwil Switzerland Tel: +41 32 720 72 24             Fax: +41 79 345 96 93Email:
  • Empresa matriz del fabricante (2017)
  • Source