Events

Alerta De Seguridad para RIA System (Reamer / Irrigator / Aspirator)

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Synthes Gmbh.

¿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
    R1611-489
  • Número del evento
    2012DM-0008758
  • Fecha
    2016-10-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=118
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has determined that the wraps for the milling wands are delaminated, which hinders the opening of the sterile wrapping and could be experienced contact non-sterile surfaces contaminating them, a situation that would lead to possible adverse events on the patients.

Device

RIA System (Reamer / Irrigator / Aspirator)
  • Modelo / Serial
    milling rod for SynReam 2.5 mm, length: 650 mm, sterile, reference 351.709S, lots || specific.
  • Descripción del producto
    The RIA system (strawberry / irrigator / aspirator) is indicated for intramedullary milling and for the extraction of bone tissue, which cleans the medullary canal of bone marrow and debris. It is also used to clean the infected bone marrow canal, efficiently determine the size of the medullary canal for the acceptance of an implant or intramedullary prosthesis. RIA works by extracting autogenous bone tissue, finely morselized and bone marrow for any surgical intervention that requires a graft of bone tissue in order to facilitate fusion or fill bone defects. These interventions may be spinal fusion, joint arthrodesis, total joint replacement, fracture repair, absence of fracture consolidation, maxillofacial reconstruction, and tumor removal.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh