Events

Alerta De Seguridad para SCIENT'X Cervical Cages, Spinal Stabilizer, Record 10306840058, Model> 11CC2AC17-5 and 11CC2AC17-6. Lots code 11CC2AC17-5: 22TT, 23TZ; 23UT and 23W7. Lots code 11CC2AC17-6: 23M2; 23SS; 23SW; 23TE; 23U4; 23W1; 2464; 246R and 247O.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Promedon do Brasil Produtos Médicos Hospitalares.; Scient’x.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1778
  • Fecha
    2015-12-22
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    According to the company, the absence of the gold wire may cause positioning error during insertion of the cage in the threaded site, which can result in neurological damage. Incorrectly positioned gold wires may cause local inflammation of adjacent fabrics that are in contact with the wire, however the consequences are limited given the biocompatibility of the gold material and the small size (0.55mm in diameter, maximum length of 2.70mm). No adverse events have been reported so far. Update of the field action: UPDATED ON 10/26/2017, the company presented the report of completion of the field action, with sending of evidences and necessary corrective actions.
  • Causa
    The device may have missing, improperly affixed and / or improperly positioned gold wire markers, which may create a 1-2mm protrusion inside or outside the cage.
  • Acción
    Pick up and return to the manufacturer. Action code: 201515554. The company guides: i. inventory inventory, and identify affected devices. Segregate them and do not use; ii. notify everyone involved in the use of the product; iii. Fill out the action evaluation document and send it to the distributor; iv. Report any adverse events occurring after implanting the product and to await the company's return with the steps to be taken regarding collection.

Device

SCIENT'X Cervical Cages, Spinal Stabilizer, Record 10306840058, Model> 11CC2AC17-5 and 11CC2AC...

Manufacturer

Promedon do Brasil Produtos Médicos Hospitalares.; Scient’x
  • Source
    ANVSANVISA