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

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.

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