Events

Notificaciones De Seguridad De Campo acerca de Pangea Spine System, and others

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia 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
    Field Safety Notice
  • Fecha
    2015-09-08
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Technique guides for the systems mentioned above describe the pedicle awls as 4.0mm for use with screws (4.0mm — 7.0mm). these awls should be used with 5.0mm — 7.0mm screws. this field safety notice is being issued in order to communicate changes being made to technique guides and outer labels in order to clarify the intended use of these two awls within these systems. there has been no change to the design or manufacture of the pedicle awls.

Device

Pangea Spine System, and others
  • Modelo / Serial
    Pangea Spine System, Technique Guide 036000.080 USS ll Polyaxial Spine System, Technique Guide 036000.216 MATRIX Spine System — Deformity, Technique Guide 036.001.180 MATRIX Spine System — Degenerative, Technique Guide 036.001.185 *Pangea Degenerative, Technique Guide 036.000.445 ’The Pangea Degenerative, Technique Guide (Technique Guide Number 036.000.445) has been added to this Field Safety Notice. Affected Labeling Description . Product Code Pedicle Awl 4.0mm wlCanevasit Handle 388.550 Pedicle Awl 4.0mm wlSiIicone Handle 388.656
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH