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Brainlab AG has issued a product notification regarding the use of the Brainlab Disposable Self-Tapping Screw 1.5 X 6MM (Art. No. 52128) / KLS Martin Cross-Drive Screw 1.5x6mm (Art. No. 25-678-06) in combination with the Brainlab Skull Reference Base (Art. No. 52121B, 52129, 52129A).
Applying too much torque or tensile force to the head of the screw during insertion and fixation of the Skull Reference Base may cause the screw head to deform or to shear off. In such case, the screw can no longer be removed using the specified screwdriver or parts of the screw may remain inside the patient¡¦s skull bone.
Depending on the used Skull Reference Base version, Brainlab AG will provide customers with updated Instructions for Use regarding safe use of the Skull Reference Array kit.
According to the local supplier, Hong Kong is affected.
For details, please refer to the attached field safety notice. If you are in possession of the affected product, please contact your supplier for necessary actions.
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