Production process analysis: a review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.User (surgeon and patient) information analysis: patient #(b)(6) index procedure performed on (b)(6) 2022.On (b)(6) 2023 apifix was notifed that patient #(b)(6) underwent revision surgery on that day due to t6 screw pull-out.During the revision the polyaxial screws were replaced with bigger screws (7.0x35) and moved up one level (t4/t5 to t5/t6).A new mid-c and extender of the same size and type were replaced.The device is not being returned to the manufacturer for analysis and will remain with the patient.Patient requested to keep the implant.Clinical affairs reviewed images from the original surgery and from the pre-op (b)(6) 2023 and could not determine if the kite angle collapsed pulling the screw with it or vice versa.Risk assessment: reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of screw pullout has been assessed and found to be acceptable the current screw pullout rate due to any reason is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.The event of screw pull-out (misplaced screws in pedicle/nut loosening from the pedicle screw & subsequent surgical interventions) is addressed in the ifu as potential risks associated with the mid-c system.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.
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