No injury to the patient or extended delay occurred do to this incident.Because, no x-ray's, patient anatomy, or implants were provided this incident will be filed as indeterminate.However, based on user feedback and conversation with the surgical rep.Potential causes for this incident can be speculated.The subject set screw was implanted into the l5 vertebral body, the middle of the l4-s1 construct, the rod was not fully reduced and seated prior to the mis tower being broken.In a conversation with the surgical rep.It was stated that the rod was particularly difficult to reduce and the construct geometry was severely curved.It is likely that the excessive upward spring force caused by the miss matched patient/construct geometry did not allow the rod and therefor set screw to be fully seated into the screw housing.When construct geometry and patient anatomy do not align in such a way large amounts of potential energy can build up in the construct, when the mis tower is broken while the set screw/rod was not fully seated there is potential that the set screw will pop out of place.Additionally, it is known that the mis dilator was used to break the mis tower which out outside of the prescribed uses.This technique could have also caused the tower to splay open allowing the unseated set screw to move out of place.The screw set screw was removed and replaced.There was no harm nor injury reported to the patient.Overall the withotu additional images or parts to be returned all items before a speculative and the case is deemed indeterminate.
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