Events

Alerte De Sécurité sur Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate 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 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
    2012-09-04
  • Date de publication de l'événement
    2012-09-04
  • 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_20120904.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: medtronic screw module used with the atlantis and premier anterior cervical plate system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning the recall of the screw module ("screw caddy") used with the atlantis anterior cervical plate system and the premier anterior cervical plate system, (part numbers176-504, 176-503, and 1860503), manufactured by medtronic limited. medtronic has discovered that the measurement gauge located on the lower corner of the caddy may be out of specification, which could cause a screw to be measured improperly. an incorrect gauge could measure a screw to be approximately 1mm shorter than its actual length. no patient injuries have been reported to date. however, using an inappropriately long screw could cause irreversible neurologic injury if it penetrated the vertebral body. 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 affected product, please contact your supplier for necessary actions. posted on 4 september 2012.

Device

Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System
  • 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