Method: x-ray review, labelling review, risk assessment.Result: the reported event was confirmed via review of the x rays, which shows 2 blockers that migrated post operatively and floating out of the screw tulip head.The patient received a revision surgery and the hospital kept the blocker for an internal investigation, so inspection could not be performed.Lot numbers were not provided, so a manufacturing review could not be performed.According to the representative, the hospital review believes the event was because of surgeon error as the blockers were inserted in the screw at a fixed angle and not seated in correctly (cross-threaded).This would cause instability in the structure and may cause the blockers to back out over time if they were not properly seated and locked down during the initial surgery.According to the representative, the surgeon applied the correct amount of torque and excessive force was not applied.As the products were not returned, a definite root cause cannot be determined.
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