A review of the manufacturing records establishes that this lot of set screw was manufactured, inspected and released to distribution with out any nonconformances.Spinefrontier investigation into this matter establishes the root cause of the occurrence was directly related to aligning the set screw.The surgical technique includes adequate instructions on set screw alignment and actions to take if the set screws does not advance with minimal resistance.The surgeon placing the device has several years of experience implanting this device and has completed numerous successful surgeries without complications.Factors relating to patient anatomy may have contributed to the reported occurrence.Spinefrotier is considering this incident closed without the need for any additional actions.
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