It was reported that 3 distal mesa polyaxial screws, on the left side, migrated post-operatively.The patient underwent initial surgery for a type c spinal cord injury of l1-l2 and spine instability.Revision surgery has occurred.This report represents the first of three screws.
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It was reported that 3 distal mesa polyaxial screws, on the left side, migrated post-operatively.The patient underwent initial surgery for a type c spinal cord injury of l1-l2 and spine instability.Revision surgery has occurred.This report represents the first of three screws.
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Functional, dimensional, and material analysis could not be performed as the device was not available.However, x-rays were reviewed and it was observed that three screws implanted at the distal end of the construct had pulled out of the bone.The subject screws were still engaged to the rod.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As the screws were not available for evaluation, the root cause could not be determined conclusively.Non-union may have contributed to the failure.Based on the radiological image, it could not be determined if fusion was achieved.Incidence of pseudoarthrosis could allow for dynamic motion within the construct, causing the implants to loosen from the bone.Device not returned.
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