Instructions for Use
TriPore Putty contains TriPore synthetic bone graft granules consisting of pure (100%) synthetic hydroxyapatite, HA, suspended in an aqueous polymer carrier gel, and is supplied in a delivery applicator.
The delivery applicator is to facilitate the delivery directly into the defect site, or the user may dispense into the hand for manual manipulation.
TriPore Putty does not set in-situ following implantation.
TriPore Putty is available in the following configurations:
||Pack or Size
TriPore with delivery applicator is supplied in a sterile sealed pouch.
DO NOT USE product if the sterile pouch is broken or has been opened.
DO NOT REUSE product –re-use results in risk of infection.
The medical professional is responsible for choosing TriPore Putty. TriPore Putty has been designed to require no additional mixing stages. TriPore Putty does not require curing, nor does it set hard. The risks associated with the use of TriPore Putty are similar to those for any HA bone graft substitute.
Sterility by route of exposure to gamma irradiation.
TriPore Putty is supplied in a sterile state. Only open the sterile pouch in a clinical environment.
TriPore with delivery applicator is for SINGLE USE only. Cannot be re-sterilised or re-used.
Instructions for use:
These instructions are guidelines and are in no way intended to modify or replace existing proven clinical procedures. Bone grafting procedures can lead to highly variable results. Normal factors which are considered for bone grafting should be utilised for TriPore. The procedure for use is as follows:
Step 1: Remove the screw cap from delivery applicator and discard it into the clinical waste.
Step 2: Push the mixture out of the barrel onto the defect site, or into the hands of the surgeon for manual manipulation.
Step 3: Using fingers, gently work the TriPore Putty into the defect to fill the spaces and irregularities.
Step 4: Secure the surgical site after implantation to prevent movement and implant migration.
Care must be taken to avoid overfilling or attempts to pressurise the defect site, as this may lead to extrusion of the product beyond the site of its intended application, potentially damaging the surrounding tissue.
Indication for use
Any spinal surgical procedure requiring bone-graft where the use of autograft would be precluded either due to the secondary effects of graft harvest (e.g. pain, disfigurement etc) or lack of autograft. This would include spinal fusion surgery in the postero-lateral gutter, posteriorly and in the interbody space.
TriPore Putty is designed for spinal use acting as a bone graft extender/ expander in non-weight-bearing applications. If weight-bearing is anticipated the graft site will need to be protected by supplemental internal and/or external fixation.
For use in skeletally mature patients, only.
There are no known side effects in using TriPore Putty over and above such effects as can be found in general bone void filling. These, include, but are not limited to: infection of the soft tissue and/or bone (osteomyelitis); adverse tissue reaction; transient hypercalcemia; incomplete bone formation or lack of bone formation; delayed union/non-union; fracture of the bone void filler with or without particulate formation; device migration or extrusion; fracture of the newly formed bone.
TriPore Putty presents no implantation risks other than those normally associated with bone void fillers. These are listed in the paragraph called ‘Side effects’.
TriPore Putty must only be used as indicated in these instructions, properly placed and contained within the spinal treatment area. Conditions which exclude the use of TriPore include:
• Infected sites
• Existence of metabolic bone disorders that affect bone and/or wound healing
• Spinal locations where the surgical site may be subjected to excessive impact or stress.
• Segmental defects, such as Segmental Spinal Dysgenesis (SSD)
• Where there is significant vascular restriction proximal to the graft site
• Patients with pre-existing calcium metabolism disorders, i.e hypercalcemia. When general bone grafting is not advisable.
Use of this device in skeletally immature patients has not been investigated.
Do not use in patients with a known calcium metabolism disorder, such as Hypercalcemia.
Not to be used in load baring applications without the use of additional fixation techniques.
Shelf life and storage
Product should be stored at standard room temperature, pressure and humidity. Not exceeding 10-70% Relative Humidity and 5-25°C (40-77°F). Do not refrigerate. Do not freeze.
The expiration date is printed on the inner and outer package labels. DO NOT USE TriPore PUTTY AFTER THE EXPIRATION DATE.
The syringe and any opened, unused or partly used TriPore granules must be disposed in clinical waste.
Orthogem Ltd, BioCity, Pennyfoot Street, Nottingham, NG1 1GF, United Kingdom