Transverse connector, micro-wound, 190 mm (Registration - STRASBOURG STRATOS OSTEOSYNTHESIS SYSTEM, Registration no. 10369290036 - Code 01410190 - batches under risk: 2011003417; 2010004014 의 안전성 경고

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 manifestation of the company, the various indications for the use of Stratos implants result in very different mechanical load characteristics. There are also factors that exert an unpredictable influence, conditioned by the patient's lifestyle after the surgery, by observing the physician's indications and by the patient's collaboration. Implants only fulfill their mission until the healing and healing of bones is complete. After that, they no longer have mechanical function, being considered foreign bodies for the locomotor system. Especially in retrosternal implantation (pectus excavatum), the risk of rupture of isolated implants presents an increased risk for the patient. It also indicates that the risk assessment is essential for the doctor. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.