Oasys midline occipital plate - used in cervical spinal fusion surgery

Related information

Hazard alert

22 July 2013

Consumers and health professionals are advised that Stryker Australia, in consultation with the TGA, has issued a hazard alert to surgeons regarding its Oasys Midline Occipital Plate.

An Oasys Midline Occipital Plate is a part of the Oasys System, which is used in spinal surgery to promote fusion and provide stabilisation at the junction between the occipital bone and the vertebrae in the cervical and thoracic spine.

Skeletal illustration of the Oasys Midline Occipital Plate showing the placement of the device along the spine Image of the pin that connects the tulip head to the plate body of the Oasys Midline Occipital Plate

It has been identified that, after the surgery, the pin that connects the tulip head to the plate body can break. This can lead to destabilisation of the plate and revision surgery may be required.

The root cause of the problem is not yet known and the manufacturer is continuing to investigate reported cases from the USA and Belgium. At the time of this hazard alert, no cases of this problem had been reported in Australia.

Information for consumers

Stryker Australia has contacted surgeons who have implanted an Oasys Midline Occipital Plate, providing further information regarding this recall and advice on how to treat affected patients.

If you have had cervical spinal fusion surgery and experience any change in symptoms (such as increased pain, weakness or numbness) or if you have any questions or concerns about this issue, please contact your surgeon or the hospital where the surgery was undertaken.

Information for all health professionals

Patients who have had cervical spinal fusion surgery and who have any questions or concerns about the above issue should be referred to their surgeon or to the hospital where the surgery was undertaken.

Information for surgeons

Stryker Australia has contacted surgeons who have implanted an Oasys Midline Occipital Plate, providing further information regarding this recall and advice on how to treat affected patients.

Stryker has received reports from the field in the USA and Belgium indicating post-operative fracture of the pin that connects the tulip head to the plate body, either as a result of an excess acute load or excess repetitive load (fatigue fracture).

To minimise risk to patients, Stryker Australia has removed this device from the market until the definitive root cause is identified.

If you have already implanted an Oasys Midline Occipital Plate, you are advised to continue undertaking routine clinical and radiographic post-operative evaluation of your patients.

If a patient with an Oasys Midline Occipital Plate reports or exhibits any change in symptoms, such as increased pain, weakness or numbness, more urgent evaluation should be undertaken.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.