Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00670-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00670-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
    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
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA