Events

Rappel de OASYS Midline Occipital Plate(Intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput –T3))

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00670-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00670-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Stryker spine has received reports from the field indicating post-operative failure of the pin that connects the tulip head to the plate body. the pin can fail when:- an excess acute load is applied to the pin causing the pin connecting the tulip to the plate to fracture; or- an excess repetitive load is applied to the pin causing the pin connecting the tulip to the plate to fracture (fatigue fracture).
  • Action
    The manufacturer, Stryker Spine is currently undertaking an investigation regarding the complaints received. In order to minimise any potential risk to patients while the investigation is ongoing, Stryker Spine recommends routine clinical and radiographic post-operative evaluation for cervical fusion patients implanted with the device. However, should the patient report or exhibit any change in symptoms such as increased pain, weakness, or numbness, more urgent evaluation should be completed. For patients who have had a revision surgery, Stryker Spine recommends routine post-operative care for revised cervical spine fusion patients. For more information, please see http://www.tga.gov.au/safety/alerts-device-oasys-midline-plate-130722.htm .

Device

OASYS Midline Occipital Plate(Intended to promote fusion of the cervical spine and occipito-cervi...
  • Modèle / numéro de série
    OASYS Midline Occipital Plate(Intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput –T3))Catalogue Numbers: 48571044, 48571045, 48571046, 48571047 and 48571048All lot numbers are affectedARTG Number: 179439
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA