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included (contraindications per IFU):\n\n* Procedures other than those stated in the INDICATIONS section\n* Coagulation disorders, or severe cardiopulmonary disease\n* Unstable vertebral fractures\n* Compromise of the vertebral body or of the pedicle walls\n* Hypersensitivity or allergy to one of the constituents of the product\n* Patient clearly improving on more conservative treatment\n* Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture\n* Paediatric patients and pregnant or breast-feeding women.","ALL","18 Years",{"count":261,"type":262},500,"ESTIMATED","OBSERVATIONAL","A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.\n\nTEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a \"real-life\" setting.\n\nThe study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.",[266,267,268],"Vertebral Fracture","Compression Fracture","Osteoporotic Fractures","2025-09-02",{"date":271,"type":272},"2025-09-09","ACTUAL",{"date":274,"type":272},"2019-09-04",{"date":276,"type":262},"2039-09-30",{"name":5,"class":6},12]