Events

Alerta De Seguridad para Instrument Implant Hip System

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 Stryker Leibinger Gmbh & Co. Kg || Stryker 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
    R1705-181
  • Número del evento
    2008DM-0002104
  • Fecha
    2017-05-18
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • 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 reports that it has detected that the screws were manufactured with the wrong material; titanium grade 4 (t014) was used instead of titanium grade 5 (t005), however, both materials are used in the manufacture of deosteosynthesis material and have a good biocompatibility behavior, however it could potentially lead to the presentation of adverse events on the patients or reinterventions.

Device

Instrument Implant Hip System
  • Modelo / Serial
  • Descripción del producto
    The material for osteosynthesis of small fragments of STRYKER is a set of plates, screws, washers and their instrumentation associated with other procedures of osteosynthesis of small bones such as: treatment and surgery of small bones, including those of the hand and wrist; internal fixation of the bones of the hand and wrist; internal fixation, reconstruction oartrodesis of small bones, including the forefoot, midfoot and hindfoot; for the treatment of: delescafoid fractures; fractures of the other carpal bones; pseudoarthrosis of the scaphoid; intercarpal arthrodesis; arthrodesis of the distal and proximal interphalangeal joints; fractures of the ulnar and radial epiphyses; osteotomies of transposition of the forefoot; for use in the internal fixation of fractures and distal radius reconstructions.
  • Manufacturer
    Stryker Leibinger Gmbh & Co. Kg || Stryker Gmbh

Manufacturer

Stryker Leibinger Gmbh & Co. Kg || Stryker Gmbh
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NIDFSINVIMA