Events

Alerte De Sécurité sur FACET WEDGE System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Depuy Synthes.

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
  • Date
    2016-10-25
  • Date de publication de l'événement
    2016-10-25
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161025a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: depuy synthes facet wedge system medical device manufacturer, depuy synthes, has issued a field safety notice (fsn) concerning its instruction for use (ifu) and surgical technique guide for the facet wedge system. the affected ifu number is se_463713 and surgical technique guide number is 036.001.121. the manufacturer issued this fsn in order to communicate changes being made to the ifu and surgical technique guide in order to clarify the intended use of the facet wedge device. the intended use section is being updated to remove stand-alone use of the facet wedge device and clarify multi-level use. in addition, further clarification is being added to the indications section in regards to pseudarthrosis. according to the manufacturer, there has been no change to the design or manufacture of the facet wedge implants or instruments. the fsn impacts information in the ifu and technique guide only. a post market clinical study conducted for the facet wedge system determined that patients implanted with stand-alone facet wedge devices may potentially display signs of radiological non-fusion. however, there have been no confirmed complaints of patient harm associated with stand-alone use of facet wedge devices to date. the customers are advised to review the revisions being made to the ifu and surgical technique guide. the updated ifu document will be included with facet wedge implants and the technique guide will become available at the manufacture’s website. for patients with stand-alone facet wedge devices implanted, there is no recommendation for prophylactic removal. patients should be monitored in accordance with standard practice for the facet wedge treatment process. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 october 2016.

Device

FACET WEDGE System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Depuy Synthes FACET WEDGE System
  • Manufacturer
    Depuy Synthes

Manufacturer

Depuy Synthes