The complainant stated that the patient presented with right flank pain and low back pain during a six-month post-operative virtual visit on (b)(6) 2018.The patient had ct scan imaging performed on (b)(6) 2018 which was forwarded to the company for review on 08/03/2018.Part numbers and lot numbers associated with this product complaint were not provided.The complainant was unable to provide information on the patient's health status or the necessity for revision surgery.The surgeon stated that the ct shows non-union at l2/3 with right side broken screw, severe right l3/4 foraminal stenosis, discussed direct lateral approach to re-fuse, but not sure this is definitively causing his pain.The surgeon stated that the patient was going to be given a right l3/4 injection, if the injection does not relieve the pain, a revision surgery will be discussed.The complainant had a meeting scheduled with the surgeon on (b)(6) 2018.The company will file a follow-up report if more information is received.The company's review of the ct images did not reveal any anatomical or placement issues, the screw and rod system appeared to be appropriately used and implanted.The broken pedicle screw was identified at the bottom of the construct at l3, at approximately half length of the screw shank.
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