Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As the device was not returned, a definite root cause cannot be determined.Possible root causes include connector in the wrong location or off- axis, hex disengagement due to cantilever force, non optimal screw placement, poor rod bending and/or hex screw initially torqued in the wrong direction.
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