On (b)(6) 2022, seaspine was made aware that a surgeon reported likely set screw loosening post-op.X-rays taken approximately 3 months after the revision surgery shows what appears to be 3 loose set screws.The customer noted that as of 07 april 2022, there is no revision surgery scheduled for this patient.No implants were made available for analysis as no revisions have occurred.Thus, no failure analysis has been performed for this complaint.
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The root cause of these events cannot be determined at this time as no implants were made available for analysis and no additional information surrounding the surgical technique and/or events leading up to the failures were provided.A singular cause in cases involving the md1-100016 point lock set screw loosening post-op is not evident.Identified associations with loss of construct rigidity include long constructs (including the s2ai spine segment), heavy intra operative clinical manipulation (e.G., spinal derotation), and method/order of construct tightening.
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