![]() 5Įlectrosurgical instruments are capable of producing radio frequency voltages of such magnitude that direct coupling can occur between the cautery tip and lead system of the generator. Physicians are advised, however, to monitor these possible effects when using OsteoGen Stimulators and the epiphysis is within the treatment area. There has not been any lengthening of the leg bones observed using OsteoGen Stimulators. The safety and effectiveness of using this device in the pediatric population has not been determined. Routine clinical observations extending over a twelve-year period on a limited number of patients treated with the OsteoGen Stimulator has not shown any evidence of excessive bone formation. The significance of these observations in humans is not known. "Attempts to produce toxicity in experimental animals have usually failed and the fact that titanium has been used in cosmetic preparations and treatment of skin disorders testifies to its relative innocuousness." 5Īnimal studies (in the rat) using capacitively coupled alternating current techniques have shown evidence of excessive bone formation. Titanium does not contain nickel, chromium or cobalt, which have been known to provoke a hypersensitivity response in some patients. While titanium has had a clinical history of nearly thirty years of use, long-term effects of implantation in humans are unknown. There are no known contraindications to the use of these devices, however, due to insufficient clinical experience, it is not recommended that it be used in the following conditions: pathological fractures due to malignant tumors or in the presence of active osteomyelitis. *OsteoGen Stimulator models currently not available. These models must be used with both leads in place, each delivering 20 microamps per lead regardless of changes in bone/tissue resistance over a range of 0-40,000 Ohms. OsteoGen 40/S, 40/M, 40/SL* & 40/ML* Stimulators are only to be used to treat multiple nonunions or in a severely comminuted nonunion where a single cathode cannot span the entire breadth of the nonunion site. OsteoGen 20/S, 20/F*, 20/M, 20/SL* & 20/ML* Stimulators should be used to treat a single nonunion and maintain a cathode current at a constant 20 microamps regardless of changes in bone/tissue resistance over a range of 0-100,000 Ohms. Rx Only - Prescription Only - Single Use Only - Do Not Reuse. Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. 5,7ĮBI OsteoGen Surgically Implantable Bone Growth Stimulators are indicated in the treatment of long bone nonunions.
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