The prolift micro expandable spacer system was unable to be returned to life spine, therefore, it is not possible to determine what was the complete failure mode resulting in the reported event.However, based on the description of the event it is hypothesized that the root cause of this failure was likely loosened set screw in the pedicle screw system (pedicle screw system not a lifespine product) leading to compromised spinal stability and therefore resulting in the flipping of the prolift micro expandable.
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