The fractured implant screw was not available to be returned to the company due to being discarded at the surgical facility.The implant system surgical technique guide provides guidance on appropriate screw insertion and angulation.Implant screws are intended to be placed at the intended 35° and driven until the implant screw passes the locking arm on the spacer faceplate.The physician was unable to place the implant screw at the proper angle, which prevented the locking arm of the spacer from securing the implant screw.A cautionary statement in the surgical technique guide states, "over-angulation of the screw beyond 3 degrees in any direction may result in failure of the screw to engage the implant and/or locking arm." the complainant reported the physician was unable to orient the implant screw at the intended 35° angle, and over torqued the driver which caused the implant screw malfunction.It was reported that the inability to place the implant screw at the proper angle was due to subpar l5-s1 exposure and patient anatomy.The physician indicated that the implant screw malfunction did not compromise the surgery or patient in any way due to posterior fixation in place from a previous surgical procedure.There is a cautionary statement included in the surgical technique guide that states, "installing fewer than three screws will significantly reduce the implant fixation and increase the risk of implant failure." there have not been any other complaints of similar nature in the past 12 months.The company will continue to monitor this product family for complaints from the field.
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