Implantable screw 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

Recall due to incorrectly etched screw size on the screw-holding clip (see picture).The use of an incorrectly sized screw could lead to clinical complications including dural injury, bleeding and failure of fracture fixation.The manufacturer has received reports of instances where the number etched on the screw holder does not match the length of the screw. This includes screws being labelled as being longer or shorter than they actually are. However, the outer packaging of the device has the correct screw size.The use of an incorrectly sized MatrixMANDIBLE, MatrixMlDFACE and MatrixORTHOGNATHlCS screw could lead to inadequate fixation or loss of fixation.The use of an incorrectly sized MatrixNEURO screw may result in a life threatening event for patients at greatest risk. If the screw is too long, the greatest risks are posed to paediatric patients, patients with skull deformities, and patients with face lesions because they are predisposed to having skulls that may not be as thick as the largest available screw (5mm). If a screw is longer than anticipated it may come into contact with the patient’s dura and small vessels.The manufacturer has recalled these devices and will be offering an alternative.