The device was not returned for evaluation.Device history records could not be reviewed without either the device or a valid lot number.Complaint history was reviewed for the reported catalog and similar complaints for were identified, originating from the same surgeon.Although post-operative x-rays were provided, the images are taken from different angles and there appears to be no discernable slip.The patient is fixated on alternating levels.Similar construct design x-rays from the same surgeon for the same failure mode were reviewed by a consultant spine health care provider on (b)(6) 2021.The physician believes that the construct design with difficult deformities was the most likely contributing factor to the event.The operating surgeon used a low density screw construct which ended on the convex curve of the spinal deformity.The low screw density and short length of construct, along with possible loss of correction, may not have been enough to counter the force of the spine trying to revert to its original position.This may have resulted in the eventual failure at the distal most screw (where biomechanical loading is most likely greater) leading to the rod slipping from the screw.It cannot be confirmed if an axial slip occurred from the images provided and a root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.
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