For this event, trending analysis revealed this issue frequently occurred when surgeons attempted to seat the baseplate/screw construct, did not gain adequate fixation, then attempted to remove the screw from the baseplate to change the screw size.Testing has confirmed that once implanted the construct becomed "married" to the point that the screw cannot be removed.This issue has been escalated within our quality system and a note explaining this screw / baseplate event will be added to the surgical technique for the device system.
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