Events

Rappel Ou Alerte De Sécurité sur Confidence Spinal Cement System

Selon Central Drugs Standard Control Organization, ce/cet/cette rappel ou alerte de sécurité concerne un dispositif en/au/aux/à India qui a été fabriqué par Depuy Spine Inc.

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
    Recall / Safety Alert
  • ID de l'événement
    31-608-MD/2009-DC (Re. Registration 2011)
  • Date
    2014-01-15
  • Pays de l'événement
    India
  • Source de l'événement
    CDSCO
  • URL de la source de l'événement
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alertes
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • Notes supplémentaires dans les données
  • Cause
    Voluntary recall has been initiated due to the reason that during injection of cement, (the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject the cement. this could result in surgical delay which could result in the need for the patient to undergo additional anesthesia as the result of another surgical procedure. the another reason has been reported that , firm reported that the cement mixer used to prepare cement for surgery has been identified to not tum properly. the event may be described as the mixer being "jammed" or "stuck" and not able to turn which could result in surgical delay in order to prepare another kit or the inability to complete the procedure if an additional kit is not available thereby exposing the patient to addtiional anesthesia in another surgical procedure.
  • Action
    Johnson & Johnson has ceased distribution of the product while evaluating appropriate corrective and preventive actions.

Device

Confidence Spinal Cement System

Manufacturer

Depuy Spine Inc