Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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It was reported in the literature titled ¿cervical pedicle screw (cps) insertion using o-arm-based 3d navigation: technical advancement to improve accuracy of screws¿ that 64 patients (31 men and 33 women) was pre-operatively diagnosed with the followings: 16 with rheumatoid arthritis, 14 with destructive spondyloarthropathy, 8 with metastatic tumor, 8 with trauma, 4 with ossification of posterior longitudinal ligament, 3 with cervical kyphosis, 3 with cerebral palsy, 3 with cervical spondylotic myelopathy, 2 with atlantoaxial osteoarthritis, 2 with atlantoaxial subluxation with unknown pathology, and 1 with klippel-feil syndrome and underwent cervical spine surgery in the spine level of c2 to c7 with cps using the intraoperative o-arm system between june 2013 and february 2020.Mean age at surgery was 67 years.Surgical technique improved in line with advances in the development of surgical instruments.Therefore, the patients were divided into 4 surgical groups based on surgical procedures.Screw accuracy was evaluated on postoperative computed tomography images.Screw accuracy was assessed using neo classification: grade (g) 0, no perforation; g1, perforation 2 mm; g2, perforation 2-4 mm; and g3, perforation 4 mm.Complications related to screw mal-positioning were also evaluated.A total of 317 cpss were placed in the spine level of c2 to c7.Eighty-three screws were placed in the first phase, 60 in the second phase, 87 in the third phase, and 87 in the fourth phase.Twelve of the 317 (3.8%) screws were mal-positioned.All 12 screws were mal-positioned in g1, and there was no g2 and g3 mal-positioning.Screw mispositioning in each phase was 6.0% (5/83) in the first phase, 8.3% (5/60) in the second phase, 1.2% (1/87) in the third phase, and 1.2% (1/87) in the fourth phase (p 0.05).Ten screws were mal-positioned laterally in phase 1 and 2, and 2 screws were mal-positioned medially in phase 3 and 4.No complications related to screw placement were observed.
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