Events

Alerte De Sécurité sur ATLANTIS™ / PREMIER® / VERTEX® Adjustable Drill Stop

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

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
    2012-03-14
  • 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_20120314c.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
    Field safety notice: medtronic atlantis™ / premier® / vertex® adjustable drill stop the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning atlantis™ / premier® / vertex® 876-460, 6860460 and 6905712 manufactured by medtronic limited. medtronic is recalling all lots of an adjustable drill stop which may be used for spinal surgery because there is a possibility that the pre-set drill depth established by the adjustable drill stop could inadvertently change during use with powered instrumentation. no patient injuries have been reported to date. however, using an 876-460, 6860460 or 6905712 adjustable drill stop could cause irreversible neurologic injury if it penetrated through the posterior cortex of the vertebral body. if this occurred, it would necessitate immediate surgical intervention repairing any damage to the surrounding vasculature/neurologic structures; the injuries could include, but are not limited to, vascular penetration, in the cervico-thoracic region and/or spinal cord damage. complications of this type of injury may lead to irreversible impairment and/or death. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

ATLANTIS™ / PREMIER® / VERTEX® Adjustable Drill Stop
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic ATLANTIS™ / PREMIERR / VERTEX® Adjustable Drill Stop
  • Manufacturer
    Medtronic Limited

Manufacturer

Medtronic Limited
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH