Events

Alerte De Sécurité sur Osteosynthesis Material for Extremities

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 Synthes 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
    R1612-566
  • Numéro de l'événement
    2011DM-0007213
  • Date
    2016-12-12
  • 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=110
  • 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 affirms that the affected lots of the referenced device may be incorrectly recorded and labeled, leading to the occurrence of possible adverse events on the patients.

Device

Osteosynthesis Material for Extremities
  • Modèle / numéro de série
    TFNA FEMORAL NAILS, reference 04.037.012S and 04.037.042S, lots H077853; H065031 and H067802.
  • Description du dispositif
    The osteosynthesis material for SYNTHES extremities are nonabsorbable implants designed to help the immobilization, stable fixation and stabilization of the osseous fragments during the treatment of fractures, trauma, reconstruction and bone deformities, restoration of anatomical relationships and allowing an accurate bone approximation. There are different types of osteosynthesis implants corresponding to the bones of the extremities of the body, for example: femur, tibia, ulna, radius, humerus, hand, foot, etc. These osteosynthesis implants can be used or not in conjunction with the other osteosynthesis implants to immobilize the affected bone and fix in such a way to induce bone growth and fracture healing. The intramedullary nails together with the locking screws are used for the osteosynthesis of large bones such as the femur, the tibia and the humerus. The osteosynthesis implants of SYNTHES are classified according to their dimensions and shapes that makes them more suitable for different parts of the extremities of the body. , its traumas and pathologies. It is noted that these implants can be combined with the original parts of the same system.
  • Manufacturer
    Synthes Gmbh

Manufacturer

Synthes Gmbh