Medical device manufacturer, Depuy Synthes, has issued a field safety notice (FSN) concerning its Instruction For Use (IFU) and Surgical Technique Guide for the FACET WEDGE System. The affected IFU number is SE_463713 and surgical technique guide number is 036.001.121.
The manufacturer issued this FSN in order to communicate changes being made to the IFU and surgical technique guide in order to clarify the intended use of the FACET WEDGE device. The intended use section is being updated to remove stand-alone use of the FACET WEDGE device and clarify multi-level use. In addition, further clarification is being added to the indications section in regards to Pseudarthrosis.
According to the manufacturer, there has been no change to the design or manufacture of the FACET WEDGE implants or instruments. The FSN impacts information in the IFU and Technique Guide only. A post market clinical study conducted for the FACET WEDGE system determined that patients implanted with stand-alone FACET WEDGE devices may potentially display signs of radiological non-fusion. However, there have been no confirmed complaints of patient harm associated with stand-alone use of FACET WEDGE devices to date.
The customers are advised to review the revisions being made to the IFU and surgical technique guide. The updated IFU document will be included with FACET WEDGE implants and the Technique Guide will become available at the manufacture's website. For patients with stand-alone FACET WEDGE devices implanted, there is no recommendation for prophylactic removal. Patients should be monitored in accordance with standard practice for the FACET WEDGE treatment process.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 25 October 2016