Potential Benefits and Risks

When compared with traditional spinal fusion treatment options:

  • The Tether™ - Vertebral Body Tethering System is designed to allow for motion at the levels treated
  • There may be smaller incisions required with The Tether™ - Vertebral Body Tethering System surgical technique (less scarring)
  • There may be less muscle and soft tissue disruption with The Tether™ - Vertebral Body Tethering System surgical technique

However, note that since this is a Humanitarian Use Device, The Tether - Vertebral Body Tethering System has not been shown to help all cases of scoliosis. Instead, The Tether has been shown to have a probable benefit. Talk with your doctor about Vertebral Body Tethering published literature that is available to the public, and what outcomes have been like for other patients.

Potential Risks and Adverse Events (AE):

  • Overcorrection of the coronal deformity, potentially requiring revision or removal of implants
  • Inadequate curve correction
  • Loss of curve correction
  • Development of new curves above and/or below the instrumented levels
  • Trunk imbalance
  • Worsening of existing deformities in non-tethered spine segments.
  • Unintended spontaneous fusion at the instrumented levels
  • Pulmonary complications including atelectasis, pneumonia, or adverse events related to temporary single lung ventilation
  • Anesthesia complications
  • Wound infection, superficial or deep
  • Wound dehiscence
  • Damage to surrounding organs and structures including blood vessels, spinal cord, nerves, lungs, or vertebral bodies
  • Vascular complications including bleeding, hemorrhage, or vascular damage leading to anemia or requiring blood transfusion
  • Neurologic complications including damage to neurological structures, cerebrospinal fluid leakage or meningocele
  • Problems during device placement including anatomic/technical difficulty and device-sizing issues.
  • Loosening or migration of the implants
  • Bending, fracturing, fraying, kinking, loosening, bending, or breaking of any or all implant components
  • Fretting and crevice corrosion at interfaces between components
  • Pain, discomfort, or abnormal sensations due to device presence
  • Material sensitivity reactions and/or particulate wear debris Systemic AEs
  • Deep vein thrombosis
  • Pulmonary embolism
  • Atelectasis, pneumonia
  • Cardiac AEs
  • Dysphagia
  • Dysphonia
  • Gastrointestinal (ileus, ulceration, bleeding, malnutrition)
  • Foreign body reaction
  • Pressure sores
  • Genitourinary (infection, urinary retention)
  • Infection (systemic)
  • Hematologic
  • Endocrine/metabolic
  • Hepatobiliary
  • Immunologic
  • Gynecologic
  • Ophthalmologic
  • Psychological
  • Surgical procedure: non-spinal
  • Wound infection: non-spinal
  • Death

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