Events

Alerte De Sécurité sur Hygiene Technical Name: Modular System for Arthroplasty Total ANVISA Registration Number: 10417940085 Hazard Class: III Model Affected: Acetabular Insert PHENOM Poly (04.13.13.xxxxx) / Acetabular Insert PHENOM Poly Rear Ceiling (04.13.14.xxxxx)

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 MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importação e Exportação de Implantes 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
    2194
  • Date
    2016-10-22
  • 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
    Non-deployed products should be segregated and returned to the MDT company and / or to customers outside Brazil, they should carry out the disposal in loco as indicated by the IU We recommend to users and patients that there are some technical complaints and adverse events involving the products mentioned in the Field Action (which can be verified on the Traceability Labels sent to each product), the Distributor and the MDT Manufacturer and / or the NOTIVISA System must be reported. To the users, it is confirmed that clinical follow-up of patients already implanted is not necessary, since possible failures are perceptible during the implantation procedure, making it possible to substitute the product and not causing a serious adverse event to the patient.
  • Cause
    In order to reduce the risks associated with the possibility of a break in the fin or impossibility of impaction of the insert due to the improper positioning of the insert in the acetabulum, the mdt company voluntarily initiated this field action for the collection of all existing products in the market, as well as , scrapping items in their own stock.
  • Action
    Field Action Code AC201601 triggered under the responsibility of the company MDT Industria Comércio Importacao e Exportação de Implantes SA Company will make collection.

Device

Hygiene Technical Name: Modular System for Arthroplasty Total ANVISA Registration Number: 1041794...

Manufacturer

MDT Industria Comércio Importação e Exportação de Implantes S.A.; MDT Industria Comércio Importaç...