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City San Clemente / / Company Actuate / MediTech Strategic Consultants B.V. / Interspinous Spacers / / Country United States / / Event Product Issues / / IndustryTerm operative site / rinse devices / unsafe product / / MedicalCondition radiculopathy / paralysis / equina syndrome / peripheral vascular disease / pneumonia / significant peripheral neuropathy / nerve injury / disease / isthmic spondylolisthesis / sterility / vertebral metastases / severe osteoporosis / stroke / allergy / symptomatic lumbar spinal stenosis / systemic disease / pain / numbness / neural compression causing neurogenic bladder / myocardial infarction / serious injury / significant scoliosis / deep vein thrombosis / Paget’s disease / spondylolisthesis / neurogenic intermittent claudication / lumbar spinal stenosis / advanced diabetes / angina / infection / thrombus / active rheumatoid arthritis / degenerative spondylolisthesis / axial back pain / back pain / bowel dysfunction / active systemic infection / morbid obesity / / MedicalTreatment spine surgery / cannula / surgery / / Organization FDA / / / Position Driver / Clinical representative for replacement / Inadequate Confidential The surgeon / local sales representative for repair or replacement / surgeon / Use The surgeon / licensed physician / / Product Interspinous Gauge / trays / instruments / Driver devices / Inserter / packaging / physical function / Confidential The surgeon / devices / / ProvinceOrState South Dakota / California / / Technology X-ray / MRI / / URL www.vertiflexspine.com / / SocialTag