Events

Alerte De Sécurité sur IMPLANT TlTAMAX CM EX 4.0X15 ACQUA, Model 140639, Registration No. 10344420072, Lot 800116123

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A..

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
    1460
  • Date
    2014-11-12
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to the company's manifestation, there is the possibility of the dental surgeon to store the implants in his office, according to the packaging, and not according to the product label, which may compromise the planning of the surgery. If the dental surgeon uses the EX CM Acqua implant in a surgical field prepared to receive a CM Drive implant, it may not be able to achieve adequate primary stability, since the sequence of drills required to implant the implants is different. In the case of low primary stability, it is not possible for the dentist to install a prosthesis (permanent or temporary) directly on the implant. In this case, the patient will need to wait for the period of osseointegration of the implant (which lasts around 6 months) so that the prosthesis can be installed and, during this time, a removable prosthesis
  • Cause
    The company that holds the registration informs that the external packaging (tertiary packaging) of the product has been exchanged. the cm ex acqua implant has been packaged for drive cm implants. the labeling of the outer packaging, traceability labels and instructions for use are according to the product inside (cm ex acqua). six units of this product were distributed.
  • Action
    The company that registers in Brazil advises dental surgeons to check their inventories and, if they identify products from the field action lot, send them to Neodent.

Device

IMPLANT TlTAMAX CM EX 4.0X15 ACQUA, Model 140639, Registration No. 10344420072, Lot 800116123

Manufacturer

JJGC INDÚSTRIA E COMÉRCIO DE MATERIAIS DENTÁRIOS S.A.