Other: infection, sensory and motor dysfunction.The following products were reported for serious adverse device effects in this clinical study: 1.Product id: 7543530, 510(k): k031655, udi: (b)(4), qty: 1.2.Product id: 75444530, 510(k): k042025, udi: (b)(4), qty: 2.3.Product id: 75445535, 510(k): k042025, udi: (b)(4), qty: 1.4.Product id: 75446535, 510(k): k042025, udi: (b)(4), qty: 1.5.Product id: 75446545, 510(k): k042025, udi: (b)(4), qty: 1.6.Product id: 75446550, 510(k): k042025, udi: (b)(4), qty: 2.7.Product id: 75447540, 510(k): k042025, udi: (b)(4), qty: 2.8.Product id: 75447545, 510(k): k042025, udi: (b)(4), qty: 3.9.Product id: 75447550, 510(k): k042025, udi: (b)(4), qty: 3.10.Product id: 75447555, 510(k): k042025, udi: (b)(4), qty: 1.Also, it is unknown whether these products caused or contributed to the reported event or not.We are filling this mdr for notification purpose.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: 21 (male: 13, female: 08); mean age: 60.6 years, mean weight: 76.5 kg; mean height: 172.1 cm social history: current smoker: yes (4 patients), no (5 patients), unknown (12 patients) primary diagnosis: spinal tumor (18 patients), m.Kahler (3 patients) groups discussed in this study: leg_v006: multi-axial or sagittal adjusting screw leg_v013: fixed angle screw it was reported in the clinical study titled ¿clinical outcomes and safety of leg_v006 and leg_v013 with minimum 12 months follow up" that 21 patients were diagnosed with spinal tumor from jan 2014 to jan 2018.Post-operatively, after 12 months follow-up, 1 patient reported sensory dysfunction and 1 patient reported both sensory and motor dysfunction.Superficial infection was reported in 1 patient while 4 patients reported deep infection.
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