Blue Sky Bio Pterygoid Implant System Instructions
- June 1, 2024
- Blue Sky Bio
Table of Contents
Blue Sky Bio Pterygoid Implant System
Instructions for Use
Blue Sky Bio, LLC Pterygoid Implant System
Indications for Use
BIO| Pterygoid System is intended for surgical placement in the bone of the
upper jaw to provide support for prosthetic devices, such as artificial teeth,
to restore chewing function. Implants may be used with single-stage or two-
stage procedures and may be
loaded immediately when good primary stability is achieved and with
appropriate occlusal loading. BIO | Pterygoid implants can be placed
bicortically in cases of reduced bone density. BIO | Pterygoid implants are
only indicated for multiple unit restorations
in splinted applications that utilize at least two implants.
Contraindications
Implants should not be placed at any time when there are general contraindications associated with elective oral surgery. Absolute and relative contraindications include but are not limited to cardiac and vascular disease, bleeding disorders, psychological disorders, uncontrolled diabetes mellitus, mineral, bone, or connective tissue disorders, renal disease, hepatic disease, auto-immune disorders decreased immune function due to disease or medications, infectious disorders, and adverse conditions caused by medications. Further, relative contraindications include poor oral hygiene, bruxism, malnutrition, alcoholism, tobacco usage, and a history of radiation therapy. In addition, the patient needs an adequate volume of residual bone for the placement of implants of sufficient size and number to support the anticipated functional loads to which the patient will be subject to these implants.
Warnings
The BIO| Pterygoid implant system is not intended for placement in maxillary
or mandibular areas where there is inadequate bone present for these implants.
BIO | Pterygoid implants are only to be used splinted in combination with at
least one other implant. Implants should be placed and restored only by
practitioners who are licensed and trained to perform these procedures.
Adequate preoperative studies should be performed to examine the anatomic
structures and to assess the biomechanical, functional, and aesthetic
requirements of each case. Radiographs or other diagnostic reviews should be
performed to determine the position and topography of the maxillary sinus,
nasal cavities, inferior alveolar nerve, mental foramen, natural tooth
positions, and other anatomical
features that may affect implant placement or prognosis.
Surgical placement of pterygoid implants is straightforward for an experienced clinician and can be performed under local anesthesia in a dental office. However, the challenges of pterygoid implant placement are the learning curve and technique sensitivity associated with the procedure and proximity to certain vital anatomic structures. Clinicians must understand surgical anatomy before placement of implants in this region. Additionally, the use of cone beam computed tomography (CBCT) imaging is recommended during treatment planning Consultation between the surgeon, restorative dentist, and dental laboratory is essential for success.
Risks of implant placement and restoration include, but are not limited to: infection, implant failure, loss of bone and soft tissue, unfavorable aesthetic results, anesthesia, dysesthesia, paresthesia in oral and facial areas, perforation of the sinus lining, sinus infection, dislodgement of implants and instruments in the surrounding structures, damage to adjacent teeth, non-restorable implants, fracture of implants or restorative components, and loosening of implants or restorative components. Each implant system has unique measuring characteristics to allow full seating of the implant to the desired depth. In some instances, drill-length reference lines measure longer than the stated length of the implant.
It is recommended that the implant surgeon be thoroughly familiar with the specific measurement system being utilized and provide a suitable safety margin adjacent to any teeth and vital structures. Failure to recognize the difference between the actual length of the drill and radiographic measurements can result in permanent injury to the nerves or other vital structures by drilling beyond the depth intended, potentially resulting in permanent numbness to the lower lip and chin or other injuries.
Each implant system has specific design characteristics for mating implants, abutments, prosthetic components, and instrumentation. Combining instruments and components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory aesthetic results. One-hundred percent success cannot be guaranteed. Lack of adequate quantity and/or quality of remaining bone, infection, inadequate surgical technique, poor patient oral hygiene, and generalized disease are some potential causes for failure of osseointegration, both immediately after surgery after osseous integration is initially achieved. Pre-operative hard tissue or soft tissue deficits may yield a compromised aesthetic result or unfavorable implant angulation. Concerning children, routine treatment is not recommended until the completion of alveolar growth has been verified.
Precaution – MRI Safety Information
Warning : The RF safety of the device has not been tested. The patient
may only be imaged when ensuring the following conditions are met.
NOTE: All metals generate image artifacts. Image artifacts in patients
with metal implants do not pose a direct hazard to the patient or a
performance issue. However, they can lead to misinterpretation of the results.
Clinical judgment should be used in the evaluation of artifacts and their
possible impact on interpretation.
Procedural Precautions, Surgery
All efforts must be made to minimize damage to the host tissue. In particular,
special attention must be paid to thermal and surgical trauma and the
elimination of contaminants and sources of infection. The surgical procedure
requires a high degree of precision and care. Any divergence from the
principle of least possible trauma at implant installation increases the risk
of failure to establish osseointegration. All drilling procedures should be
performed at a maximum of 1000-2000 RPM with copious irrigation. The use of
sharp drills, sufficient irrigation, an in-and-out drilling motion, short
cutting cycles, waiting for the bone to cool, and the use of pilot drills in
successively increasing sizes is essential.
Special care should be taken to avoid over or under-preparation of the osteotomy. Implants should be inserted in such a way that they are stable and lack any mobility. Excessive insertion torque (greater than 60 Ncm) may lead to damage to the implant or instruments and fracture or necrosis of the bone site. All instruments used in surgery must be maintained in good condition and care must be taken that the instruments do not damage the implants or other components. Precautions must be taken to avoid the swallowing or aspiration of components used in implant dentistry. After the implant installation, the surgeon’s evaluation of bone quality and initial stability will determine when implants may be loaded. An appropriate follow-up protocol should be followed.
NOTE: Consult Surgical Instructions for individual implant procedures and
drill sequences. https://blueskybio.com/pages/instructions-for-use
Instructions for Abutments for Restoration of Blue Sky Bio Implants BIO |
Pterygoid implants may be loaded immediately when good primary stability is
achieved and with appropriate occlusal loading. For BIO| Pterygoid implants, a
final abutment with appropriate angulation should be selected. The indexing
feature of the abutment (e.g. hexagon) should match the internal indexing
feature of the implant. Adequate seating can be verified with a radiograph.
Seating should be performed using an insertion driver compatible with the
selected implant system and a torque wrench applying 30 Ncm of torque on the
abutment or
fastening screw.
In case of delayed loading, after adequate osseointegration, the implants should be uncovered, if necessary, and the cover screw or protective healing cap should be removed. The internal part of the implant should be irrigated, free of debris, and dried. If necessary, a healing abutment should be placed and the tissue should be allowed to heal around the healing abutment. A final abutment that is compatible with the implant should be chosen and inserted as described above once the tissue has healed. A restoration should be fabricated and inserted after the tissue has healed, while making sure that the restoration has a passive fit, is stable, and the occlusal load is appropriate.
Follow Up Care
Patients should be instructed in appropriate oral hygiene and care of the
implants and restorations. Periodic follow-up appointments should be made to
confirm and maintain adequate function of the implants and the health of the
surrounding tissues.
Sterility
All implants are supplied sterile and are for single use only before the
labeled expiration date. Do not use implants if the packaging has been damaged
or previously opened. Abutments, abutment screws, and instruments are supplied
non-sterile and must be cleaned and sterilized before use. The recommended
sterilization cycle is moist heat (steam), gravity displacement, wrapping,
30-minute exposure at 121 °C (250 °F), and 15 minutes of drying. Use a wrap
that is FDA-cleared for the indicated cycle.
Method of Supply
Blue Sky Bio implants, abutments, and abutment screws are made out of medical-
grade titanium alloy (Ti-6Al-4V).
Caution
The sale of this device is restricted to, or by the order of, licensed
physicians or dentists.
Implant Card Instructions for Completion
An implant card has been provided with the implant device. It is intended to
be completed by the healthcare provider; and then given to the patient.
- Name of the patient or patient ID – To be completed by healthcare institution/provider
- Date of implantation – To be completed by healthcare institution/provider
- Name and address of the healthcare institution and provider – To be completed by the healthcare institution/provider
- Barcode to patient implant information – Present on Implant Card
Locations of text to be filled on the Left. An example of a completed implant card on the right with written information in blue. Symbolling located on the device-specific side of the implant card can be found on the first page of the IFU.