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Device Description

The IlluminOss Photodynamic Bone Stabilization System is comprised of a single use disposable procedure pack, along with a reusable curing system and instrument kit.

Intended Purpose / Indication

The Photodynamic Bone Stabilization System is indicated for use in fracture alignment reduction.  It provides stabilization for bone fractures using a minimally invasive technique in which the bone is not subjected to significant weight bearing forces.  This IlluminOss procedure pack is intended for use in treatment of the metacarpal, phalange, clavicle, radius, ulna, distal radius, olecranon and fibula.  It is also indicated for the treatment of impending and actual pathological fractures of the humerus from metastatic bone disease.

Contraindications

For all bones:

  • Patients who are considered skeletally immature.
  • Presence of active or incompletely treated infections that could involve the site where the device will be implanted.
  • Patients allergic to any of the implant materials, or to dental glue.
  • Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
  • Uncooperative patient or patient with neurologic disorder, incapable of following directions.
  • Distant foci of infections which may spread to the implant site.
  • Vascular insufficiency.
  • Open fractures with severe contamination.
  • Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
  • Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.

For all bones excluding Humerus:

  • Metabolic disorders which may impair bone formation.
  • Osteomalacia.
  • Vascular insufficiency, muscular atrophy, or neuro-muscular disease.

Warnings

  • Do not reuse or attempt to re-sterilize the disposable components, doing so may result in injury or death.
  • Discard and do not use opened or damaged packages.  Do not use if there is a loss of sterility of the polymer or other kit components.
  • Do not utilize any component after the expiration date.
  • Correct selection of the implant diameter and length is extremely important, before implantation:
  • Ensure the implant is long enough to span the fracture, and is not longer than the canal.
  • Ensure the separation instrument can reach the balloon.
  • The polymerization (curing cycle of implant) is a short-term exothermic reaction.
  • Do not insert or affix sutures, K-wires, or other hardware to or through the stabilization balloon until cured.
  • If simultaneous fractures of the tibia and fibula of the lower extremity require surgical reduction and stabilization: the tibial fracture should be adequately treated using conventional methods prior to use of the IlluminOss device to treat the fibular fracture.
  • Do not utilize the system for treatment of tibial fractures.
  • If simultaneous fractures of the radius and ulna of the upper extremity require surgical reduction and stabilization: the surgeon should consider use of conventional methods of fixation for one bone fracture, and the IlluminOss device to treat the fracture of the other bone.
  • Do not attempt to inflate the balloon catheter by use of any ancillary inflation equipment.  Properly sized inflation syringes and the amount of polymer necessary to accomplish the appropriate inflation are provided.  The balloon is made of a non-compliant, thin walled PET and does not expand larger than its prescribed size.
  • Do not add any material or fluids to the polymer.
  • Do not expose polymer to any light source other than the IlluminOss Photodynamic Curing System, shield polymer from light after removal from vial.
  • If, upon fluoroscopic examination, the user determines that the inflated balloon is not in contact with the intramedullary canal of the bone, the user should remove the balloon prior to curing the polymer, reassess sizing, and replace it with the appropriately sized balloon.
  • Do not activate the light source until the balloon catheter is in the appropriate position and the bone fracture is reduced and ready for stabilization.  Activation of the light source in the presence of the polymer will initiate polymerization, an irreversible process.
  • The polymer must be exposed to the IlluminOss Photodynamic Curing System for a specific amount of time in order to activate and fully cure the implant.  A partially cured implant cannot be used to complete a procedure.  If an uncured, or partially cured implant is suspected, or if a curing cycle is interrupted, additional curing cycles should be completed.
  • Inadequate postoperative fixation or unanticipated postoperative events may affect the interface between the bone and stabilization balloon, which may lead to micro-motion of the implanted balloon and balloon surface.  Periodic follow up examinations and radiographs are advised for all patients.
  • Deep wound infection is a serious postoperative complication and may require total removal of the stabilization system and embedded polymer.  Deep wound infection may be latent and not manifest itself for several years post- operatively.

Precautions

  • Read instructions prior to use.
  • Prior to using the IlluminOss Photodynamic Bone Stabilization System, surgeons should, through specific training and experience, be thoroughly familiar with the properties, handling characteristics, and application of the system.
  • Strict adherence to good surgical principles and technique are required during the use of the IlluminOss Photodynamic Bone Stabilization System.
  • The polymer in liquid form may cause sensitization by skin contact.  In case of contact with skin, wash immediately with soap and water.

Risks

For all bones

As with any IM fixation system or rod the following can occur:

  • loosening, bending, cracking or fracture of the components or loss of fixation in bone attributable to delayed union, nonunion, insufficient quantity or quality of bone or markedly unstable comminuted fractures
  • loss of anatomic position with nonunion or malunion with rotation or angulation
Specific to the Humerus
  • the risk of fatty embolism in this patient population should be addressed and monitored