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

Recall

RC-2013-RN-00670-1

Class II

2013-07-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00670-1

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).

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 .