Events

Alerta De Seguridad para High Viscosity Spinal Cement CONFIDENCE

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Teknimed S.A.S. || Depuy Spine, Inc. || Medos International Sarl.

¿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
  • ID del evento
    R1712-574
  • Número del evento
    2009DM-0004623
  • Fecha
    2017-12-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=61
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected that due to a manufacturing error, the referenced devices may contain variable amounts of contrast medium below the specification, causing the impairment of visibility under x-rays, resulting in possible intraoperative and postoperative damage, the health professionals that they have implanted patients should continue the follow-up according to the usual care protocol, since the situation described could lead to possible adverse events on the patients.

Device

High Viscosity Spinal Cement CONFIDENCE
  • Modelo / Serial
    283910000, 283913000, lots 129385 129386 133829 133831 133825
  • Descripción del producto
    Indicated for the percutaneous application of CONFIDENCE spinal cements, used for the fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures can be caused by osteoporosis, benign lesions (hemangiomas) and malignant lesions (metastatic cancer, myeloma ).
  • Manufacturer
    Teknimed S.A.S. || Depuy Spine, Inc. || Medos International Sarl

Manufacturer

Teknimed S.A.S. || Depuy Spine, Inc. || Medos International Sarl
  • Source
    NIDFSINVIMA