Events

Alerta De Seguridad para hydroxyapatite of bovine origin Endobon

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 Biomet 3I Inc..

¿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
    R1601-33
  • Número del evento
    2009DM-0004199
  • Fecha
    2016-01-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=160
  • 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 in studies of cytotoxicity of the referenced product have shown a level 4 level for a study period of 36 months, however clarifies that for shorter periods (about 25 months approximately) the results have shown that there is no cytotoxicity, leading to potentially present adverse events on patients by exceeding the times determined as safe.

Device

hydroxyapatite of bovine origin Endobon
  • Modelo / Serial
    ROX05, ROX10, ROX20, ROXLG20, ROXLG50 and ROXLG80, with useful life time between January 2016 and September || 2018
  • Descripción del producto
    To permanently reconstruct uninfected bone defects. Filling of defects by resection of osseous tumors or bone cysts, bone defects after apicoectomy, filling of periodontal pockets in the lower maxilla, filling of "fresh" alveoli after extractions, osteotomy of the jaws.
  • Manufacturer
    Biomet 3I Inc.

Manufacturer

Biomet 3I Inc.
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NIDFSINVIMA