Events

Alerte De Sécurité sur Osteosynthesis material

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Importacao e Exportacao Ltda.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1708-354
  • Numéro de l'événement
    2014DM-0002409-R1 ; 2014DM-0002401-R1 ; 2009DM-0005041
  • Date
    2017-10-24
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=67
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Invima informs that through ivc's visit it was possible to prove that the referenced product was marketed and implemented without meeting the full requirements of the technical and legal provisions that regulate it, for which the product was withdrawn from the market in a preventive manner, as it is considered a fraudulent product.

Device

Osteosynthesis material
  • Modèle / numéro de série
  • Description du dispositif
    MDT / BIOTECHNOLOGY joint replacement prostheses are indicated for joint replacement procedures of the shoulder, knee and hip, whether total, partial, modular or revision. Their purpose is to replace the osseous and joint stabilization components for joint function reconstruction in patients with joint damage as a result of pathologies, among others: -non-inflammatory degenerative joint disease (osteoarthritis), -vascular necrosis, -osteoarthritis secondary to trauma, -sequences of trauma, -anquilosis-surgical arthrodesis.
  • Manufacturer
    Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Importacao e Exportacao Ltda

Manufacturer

Mdt Indústria Comércio Importação e Exportação de Implantes S.A. || Biotechnology Ortopedia Impor...
  • Source
    NIDFSINVIMA