Events

Alerte De Sécurité sur Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumbar distractor 3.5x10 - Lot 856; HRCID11 - Fine lumbar distractor 3.5x11 - Lot 883, record 10355870048, risk class I.

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 Biomedica Equipamentos e Suprimentos Hospitalares Ltda.; Eurospine.

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
    1813
  • Date
    2016-02-01
  • 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 registry holder, there are no negative impacts related to the patient, because the breaks occurred in the rod near the cable, externally to the patient, without the production of debris. There are also no risks related to lack of surgery, as the manufacturer also offers a series of "monobloc" lumbar distractors (HRCIDx / x references) that can be used instead of the instruments used for this recall.
  • Cause
    According to the record holder there may be breakage of the cable of two surgical instruments that may have been caused by the soldering point or deviations in its form of use.
  • Action
    Pick up and return to the manufacturer. Action code: 00003. It is recommended to stop immediately the use of the affected products and their segregation, with subsequent return to the importer; the importer will be responsible for returning the instruments affected to the manufacturer, as well as the replacement of the items collected to the customers. It is also recommended that any adverse events noted should be reported to the importer and to the competent health authority.

Device

Eurospine instruments, HRCID09 models - 3x9 thin lumbar distractor - Lot 883; HRCID10 - Fine lumb...

Manufacturer

Biomedica Equipamentos e Suprimentos Hospitalares Ltda.; Eurospine
  • Source
    ANVSANVISA