The crack in the product's quick-rail is due to improper handling (e.G.Products dropped), although it does not represent any restrictions with regard to the safety and/or effectiveness of the product and cannot have contributed to the incident described by the customer.The measured clamping pressure values of the product's torque screw are below specification.The pressure measurement of the skull clamp must be checked regularly.The maintenance interval of one year specified in the instructions for use of the product was exceeded by the customer by 1 year and 4 months.The device was therefore not checked regularly as part of the annual maintenance program.A possible deviation in the clamping force of the product's torque screw or in other features of the product may remain undetected if the maintenance interval is not met.All other features of the appliance in question comply with the specification and do not exhibit any defects in terms of functionality and safety.The customer is advised of his obligations to comply with the maintenance interval and the associated periodic servicing to ensure the safety and effectiveness of the product.From our experience the pinning technique is decisive when it comes to slippages.It can not be excluded that in this case, the pinning technique has not been optimal as described in the instruction manual: "adjust the skull clamp to the width of the patient's head in the manner that the two skull pins in the rocker arm are equidistant from the centerline of the head and the single skull pin at the extension assembly is in line with this centerline.".
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