Events

Alerte De Sécurité sur Instrument Implant Hip System

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Stryker Leibinger Gmbh & Co. Kg || Stryker Gmbh.

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
    R1705-181
  • Numéro de l'événement
    2008DM-0002104
  • Date
    2017-05-18
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=88
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    NIDFSINVIMA