Events

Alerte De Sécurité sur Transverse connector, micro-wound, 190 mm (Registration - STRASBOURG STRATOS OSTEOSYNTHESIS SYSTEM, Registration no. 10369290036 - Code 01410190 - batches under risk: 2011003417; 2010004014

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 Orcimed Industria e Comercio Ltda.; MedXpert GmbH.

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
    1524
  • Date
    2014-12-19
  • 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 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.
  • Cause
    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