EBI Bone Healing

Product information on the Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System

INDICATIONS: The Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System is a non-invasive spine fusion stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels – P850022/S017.

USAGE: The SpinalPak Non-invasive Spine Fusion Stimulator System is designed to deliver 270 days of continuous therapeutic treatment for 24 hours per day. The recommended daily therapeutic treatment is continuous for 24 hours. Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Rx Only – Prescription Only – Single Patient Use Only – Not for Re-Sale or Re-Distribution – Do Not Reuse.

CONTRAINDICATIONS: There are no known contraindications regarding the use of the Biomet SpinalPak Spine Fusion Stimulator System.

WARNINGS: The concomitant use of the device and a pacemaker or cardioverter must be assessed on an individual basis, such as with an electrocardiogram, prior to use. The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active Biomet SpinalPak Non-invasive Spine Fusion Stimulator System device. If there are any observable adverse changes in the pacemaker rhythm or output, the device should not be used.

The safety and effectiveness of the Biomet SpinalPak Non-invasive Spine Fusion Stimulator System in pregnant women have not been studied, and the effects of the device on the mother or the developing fetus are unknown. A patient who is either pregnant or is intending to become pregnant should be referred to her doctor prior to treatment with the device.

PRECAUTIONS: The Biomet SpinalPak Non-invasive Spine Fusion Stimulator System has not been studied in individuals with the following conditions: spondylitis, infection, Paget’s disease, cancer, diabetes mellitus, renal disease, trauma of the lumbar spine and osteoporosis: therefore, the safety and effectiveness of the device in these individuals is unknown.

PATIENTS:

Complete prescribing information including warnings and precautions associated with the use of this device may be found online at Bone Healing,  or by contacting customer service at 1-800-526-2579, extension 6000.

If you have additional questions regarding your doctor’s instructions in using this device, or you are experiencing any type of adverse reaction with the use of this device, contact your doctor immediately. For further product information, including warnings, refer to the Patient Manual PN1067796-00 at Bone Healing, or contact Customer Service at 1-800-526-2579, extension 6000.

Product information on the Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System

INDICATIONS: The Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when there are no visibly progressive signs of healing  – P850022/S017.

USAGE:  The OrthoPak Non-invasive Bone Growth Stimulator System is designed to deliver 270 days of continuous therapeutic treatment for 24 hours per day. The recommended daily therapeutic treatment is continuous for 24 hours. Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Rx Only – Prescription Only – Single Patient Use Only – Not for Re-Sale or Re-Distribution – Do Not Reuse.

CONTRAINDICATIONS: The use of this device system is contraindicated if the individual has synovial pseudarthrosis.

WARNINGS: Utilization of this stimulator allows full weight bearing on the casted extremity unless gross motion (greater than 5 degrees in any plane) at the nonunion site is present. In such a case, weight bearing is not advised and should not be permitted as this may compromise the effectiveness of the treatment. The safety and effectiveness of the use of the device on individuals lacking skeletal maturity has not been established. Animal safety studies indicate that the device does not interfere with the normal intrinsic activity of the heart. However, the stimulator does interfere with the operation of certain pacemakers. The concomitant use of the device and a pacemaker must be assessed on an individual basis, prior to use (such as with an electrocardiogram).

PRECAUTIONS: Although laboratory teratological studies performed with this device demonstrate no adverse findings, the safety of this device used during pregnancy and nursing in humans has not been established.

PATIENTS:

Complete prescribing information including contraindications, warnings and precautions associated with the use of this device may be found online at Bone Healing,  or by contacting customer service at 1-800-526-2579, extension 6000.

If you have additional questions regarding your doctor’s instructions in using this device, or you are experiencing any type of adverse reaction with the use of this device, contact your doctor immediately. For further product information, including warnings, refer to the Patient Manual PN1067800-00 at Bone Healing, or contact Customer Service at 1-800-526-2579, extension 6000.

Product information on the Biomet® EBI® Bone Healing System

INDICATIONS: The Biomet® EBI® Bone Healing System is indicated for the treatment of fracture nonunions, failed fusions, and congenital pseudarthrosis in the appendicular system. A nonunion is considered to be established when there are no visibly progressive signs of healing  – P790002/S028.

USAGE: The recommended daily treatment dosage is normally 10 hours per day. The maximum recommended therapeutic treatment period is nine months (approximately 270 days). This device system is a durable therapeutic electrical device intended for single patient use only under a prescription. Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician. Rx Only – Prescription Only – Single Patient Use Only – Not for Re-Sale or Re-Distribution – Do Not Reuse.

CONTRAINDICATIONS: Nonunion fractures in which a synovial pseudarthrosis (fluid filled gap) exists.

Under certain conditions, electromagnetic stimulation could inhibit or impair the functioning of certain external, non-invasive and/or implanted, invasive active medical devices inclusive of “all active electrical and non-active conductive/metallic implants”. Use of the Biomet EBI Bone Healing System on pregnant patients has not been evaluated; therefore, it is not recommended. MRI scans should not be performed on patients until the device system has been completely removed.

WARNINGS: Use of the Biomet EBI Bone Healing System for the spine and skull have not been evaluated.

PRECAUTIONS: Nonunion fractures with gaps in excess of 1.0 cm or the presence of fixation devices or instrumentation made from magnetic materials may compromise a successful treatment outcome.

PATIENTS:

Complete prescribing information including contraindications, warnings and precautions associated with the use of this device may be found online at Bone Healing, or by contacting customer service at 1-800-526-2579, extension 6000.

If you have additional questions regarding your doctor’s instructions in using this device, or you are experiencing any type of adverse reaction with the use of this device, contact your doctor immediately. For further product information, including warnings, refer to the Patient Manual PN1068243-00 at Bone Healing, or contact Customer Service at 1-800-526-2579, extension 6000.

*This website contains educational information for patients and their caregivers about electrical stimulation medical devices that have been prescribed by a qualified healthcare professional for their specific use.

The content being provided is not intended or recommended for patients or their caregivers as a substitute for medical advice, diagnosis, or treatment. Patients must always consult with a qualified healthcare professional regarding their diagnosis and treatment.