General Consideration Points
- Fracture stabilization cannot be assured when the IlluminOss implant is not in contact with the cortical wall or if the implant is moving within the intramedullary canal. The implant diameter should be of sufficient size so that it achieves circumferential conformal contact with the walls of the intramedullary canal. Select a balloon diameter equal to or slightly larger than the largest canal diameter observed.
- In cases where there may be some doubt on the correct diameter implant (e.g. eccentrically shaped canal), always use the next larger size diameter implant.
- Reduce the fracture prior to the placement of the implant; the inflation of the IlluminOss implant will not reduce a fracture.
- Do not attempt to reduce a fracture or adjust the rotational alignment with an implant inflated and in contact with the cortical walls as this may cause a tear in the implant. Reduce the volume of an implant by withdrawing some of the monomer prior to adjusting the reduction.
- The IlluminOss implant is constructed from a thin wall PET balloon. Do not bring instruments (K wires, screws, suture needles, clamps or other instruments) to come in contact with the implant prior to it being fully cured as it may damage or compromise the implant.
This product is contraindicated in patients who have an active or incompletely treated infection that could involve the site where the device will be implanted; are allergic to any of the implant materials or to dental glue; have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture; distant foci of infections which may spread to the implant site, have open fractures with severe contamination; or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.
- This device has not been studied in patients who are skeletally immature.
- Do not reuse or attempt to re-sterilize the disposable components.
- Discard and do not use opened or damaged packages. Do not use if there is a loss of sterility of the monomer or other kit components.
- Do not utilize any component after the expiration date.
- Correct selection of the implant diameter and length is extremely important, and should be determined before implantation:
- Ensure the implant is long enough to span the fracture, and is not longer than the canal
- Ensure that the implant diameter is large enough to ensure cortical contact.
- 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 after it has cured.
- Do not attempt to inflate the balloon catheter by use of any ancillary inflation equipment. Properly sized inflation syringes and the amount of monomer 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 monomer.
- Do not expose monomer to any light source other than the IlluminOss Photodynamic Curing System, shield the monomer 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 monomer, 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 monomer will initiate polymerization, an irreversible process.
- The monomer 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 a 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.
As with any IM fixation system or rod the following can occur:
- loosening, bending, cracking, fracture, or mechanical failure of the components or loss of or inadequate fixation in bone attributable to delayed union, nonunion, insufficient quantity or quality of bone, markedly unstable comminuted fractures, or insufficient initial fixation
- loss of anatomic position with nonunion or malunion with rotation or angulation
- adverse tissue reaction
- infection, including wound complications
- thromboembolic event or fat embolism (blood clot, fat, or other material that could result in organ damage or failure)
- implantation-related bone fracture
- soft tissue damage
- pain and/or loss of function
- inability to properly deploy or remove device
Risks specific to a photodynamic curing system can include:
- malfunction of photodynamic process
- lack of electrical safety or electromagnetic compatibility
- unacceptable exothermic reaction
- balloon leakage
- 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 monomer in liquid form may cause sensitization by skin contact. In case of contact with skin, wash immediately with soap and water