Events

Alerte De Sécurité sur hydroxyapatite of bovine origin Endobon

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 Biomet 3I Inc..

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
    R1601-33
  • Numéro de l'événement
    2009DM-0004199
  • Date
    2016-01-27
  • 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=160
  • 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
    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
  • Modèle / numéro de série
    ROX05, ROX10, ROX20, ROXLG20, ROXLG50 and ROXLG80, with useful life time between January 2016 and September || 2018
  • Description du dispositif
    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.
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “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