BLUE SKY BS-LS-0164 Zygomatic Implant Systems Instruction Manual

Instructions For Use
Blue Sky Bio, LLC
Zygomatic Implant Systems

BS-LS-0164 Zygomatic Implant Systems

Blue Sky Bio, LLC
800 Liberty Dr Libertyville,
IL 60048 USA

| CATALOG NUMBER
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| CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR PROPERLY  LICENSED PRACTITIONER
| DO NOT USE IF PACKAGE IS DAMAGED
| USE BY DATE
| DO NOT REUSE
| MANUFACTURED BY
| BATCH CODE
| ELECTRONIC INSTRUCTIONS FOR USE
| CAUTION, CONSULT ACCOMPANYING DOCUMENTS
| STERILIZED USING GAMMA RADIATION
| NON-STERILE

Indications

Blue Sky Bio Zygomatic Implant System is indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Blue Sky Bio zygomatic implants are recommended for the posterior  (pre-molar/molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Blue Sky Bio zygomatic implants may be loaded immediately when good primary stability is achieved and with  appropriate occlusal loading.

Contraindications

Implants should not be placed anytime 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 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 subject these implants.

Warning

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  esthetic requirements of each case.
Radiographs or other diagnostic reviews should be performed to determine 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. 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 result, anesthesia, dysesthesia and paresthesia in the oral and facial areas, 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. These implants should not be used on patients with known hypersensitivity or allergic reaction to titanium alloys.
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 or after osseointegration is initially achieved. Pre-operative hard tissue or soft tissue deficits may yield a compromised aesthetic result or unfavorable implant angulation. With respect to children, routine  treatment is not recommended until completion of alveolar growth has been verified.

Precaution – MRI Safety Information

The Blue Sky Bio Zygomatic Implant System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the Blue Sky Bio Zygomatic Implant  System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

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 to 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 maximum 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 use of pilot drills in successively increasing sizes are essential. Please refer to our web site for the specific sequence of drills for each  implant type and size. 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  o  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.

Procedural Precautions, Prosthetics

Especially important is proper stress distribution through passive adaptation and fitting of the bridge to the implant abutments, adjusting occlusion to the opposing jaw, and avoiding excessive transverse loading forces. Immediate loading and immediate  temporization require additional precautions and are not suitable for all cases. Because of the small size of prosthetic components, care must be taken that they are not swallowed or aspirated by the patient.
Angled abutments and unplanted narrow implants should not be used in the posterior area of the mouth.

Instructions for Abutments for Restoration of Blue Sky Bio Implants

After adequate osseointegration the implants should be uncovered, if necessary, and the cover screw should be removed. The internal part of the implant should be irrigated, freed from 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.
If the abutment is modified at chair side, it is advisable to make an impression and make a preliminary model to identify any undercuts prior to making the final impression. A carbide or diamond bur can be used with copious irrigation to remove the undercuts.
The indexing feature of the abutment (e.g. hexagon or square) should match the internal indexing feature of the implant. Adequate seating can be verified with a radiograph.
If the abutment is modified in a laboratory, proper orientation of the abutment into the implant should be identified by means of a transfer jig or any other transfer device. Final abutment 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.
Abutments should not be over-prepared, and the retention of restoration and the strength off the abutment should be taken into consideration. It is recommended that less than 50% of the structure of customizable abutments and less than 30% of straight  abutments be removed.
Modifying the abutment at the junction with the implant is not recommended.
A restoration should be fabricated and inserted, while making sure that the restoration is stable and occlusal load is appropriate. One piece implants require intraoral modification of the abutment portion of the implant. The implant should not be overprepared  to avoid fracture of the implant.

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 prior to 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 prior to use. The recommended method is moist heat (steam) sterilization cycle: gravity-displacement, wrapped, 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

Federal law restricts this device to sale by or on the order of a physician or properly licensed practitioner.

Manufactured by:
Blue Sky Bio, LLC
800 Liberty Drive
Libertyville Il 60048 USA

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