Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Orcimed Industria e Comercio Ltda.; MedXpert GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1524
  • Date
    2014-12-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    The manufacturer of the product evaluated the possibility of rupture of the transverse rods / connectors of the stratos system in patients operated for more than 18 months to correct pectus escavatum with the ravich technique. the company received adverse event notification (implant break) in a patient operated for more than two years. as a result of the research process the product failure was attributed to the implant capacity overload.
  • Action
    The company that registers in Brazil advises that implants should be removed approximately 12 to 18 months postoperatively. In all cases, postoperative monitoring of the patient is mandatory. It is recommended that patients be examined at appropriate intervals (all 4 to 6 months). In all post-operative examinations, chest x-rays should be taken at two levels to check if the reconstruction is intact. The decision on the removal of the implant and the time of execution should be evaluated on a case-by-case basis, according to the extent, location and possible discomfort of the patient.

Device

Transverse connector, micro-wound, 190 mm (Registration - STRASBOURG STRATOS OSTEOSYNTHESIS SYSTE...

Manufacturer

Orcimed Industria e Comercio Ltda.; MedXpert GmbH
  • Source
    ANVSANVISA