Others: deep infection.The following products were used in the 6 patients covered in this clinical study: product id: 75476540, qty: 2.Product id: 75476545, qty: 4.Product id: 75476550, qty: 1.Product id: 75477535, qty: 2.Product id: 75477540, qty: 6.Product id: 75477545, qty: 13.Product id: 75477550, qty: 7.Product id: 75477555, qty: 4.It is unknown which of the above implants was responsible for the reported adverse event.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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No.Of patients: 06 (male: 02, female: 04); mean weight: 78.5 kg; mean age: 59.8 years; mean height: 167.7 cm current smoker: yes (01 patient), no (04 patients), unknown (01 patient) pre-operative diagnosis: degenerative lumbar scoliosis (05 patients), m.Bechterew (01 patient) study group: fnsl_v003: multi-axial or sagittal adjusting screw it was reported per a clinical study titled ¿clinical outcomes and safety of fnsl_v003 with minimum 12 months follow up" that 06 patients were diagnosed with spinal deformity from jan-2014 to jan-2018.Post-operatively, 1 patient suffered from deep infection and malposition of screw.This patient then underwent screw re-positioning surgery at the target level.
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