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BioHorizons Customer Care or your local representative with any questions you have regarding a specific IFU. Any serious
incident that has occurred in relation to the device should be reported to the manufacturer and competent authority of the EU
Member State in which the clinician and/or patient is established.
Prosthetic Instruments - Only use a torque wrench for final installation of prosthetic components requiring a specified installation
torque. Finger-tightening of prosthetic components can result in insufficient torque and eventual loosening of the component.
Over-tightening prosthetic components could break the component or spin the mating implant.
COMPLICATIONS AND ADVERSE EFFECTS
The risks and complications with instruments, prosthetics, and implants include, but are not limited to: (1) allergic reaction(s) to
implant and/or abutment material; (2) breakage of implant required to be explanted and/or abutment required to be removed using
clinician judgement; (3) abutment screw and/or retaining screw loosening; (4) infection requiring revision of the dental implant;
(5) nerve damage that could cause permanent weakness, numbness, or pain; (6) histologic responses possibly involving
macrophages and/or fibroblasts; (7) formation of fat emboli; (8) implant loosening requiring revision surgery; (9) maxillary
sinus perforation; (10) labial or lingual plate perforation; and (11) bone loss possibly resulting in revision or removal.
HANDLING AND STERILIZATION
Always handle the product with powder-free gloves and avoid contact with hard objects that may damage the surface. If the
product is supplied sterile, it should be considered sterile unless the package has been opened or damaged. Using accepted
sterile technique, remove product from the package only after the correct size has been determined. If the product is supplied
non-sterile or when reprocessing: Remove and discard any shipping material before initial sterilization. Assembled instruments
(e.g. ODSecure Cap Insert/Extract Tool (ODSCT)) should be disassembled before each cleaning and sterilization cycle to avoid
debris encapsulation, material discoloration and/or inappropriate drying of components. Disassemble the surgical kits before
each cleaning. The device must be cleaned and sterilized. The following cleaning protocol must be used:
1) Prepare a detergent bath in a sterile container using a broad-spectrum cleaning or disinfecting agent such as Hu-
Friedy's Enzymax® per the manufacturer's recommendations.
2) Brush the product to remove visible debris using a soft bristled brush moistened with the prepared detergent solution.
3) Thoroughly rinse product under running utility tap water.
4) Place product in the sterile container filled with the prepared detergent solution and sonicate for ten (10) minutes.
5) Thoroughly rinse product under running utility tap water.
6) Spray or wipe product with 70% IPA.
7) Blot product dry with clean lint free cloth.
(For AS123 Hand Unit: blow pressurized air through one of the four drain holes to purge. CGS Quick Connect Handle: blow
pressurized air through one end to purge. For both instruments: use a medical instrument lubricant such as STERIS' Hinge
Free® after each use.) Refer to the labeling of the cleaning/lubricating agent used for instructions for use. Instruments that are
unable to be cleaned, discolored, do not properly interface with mating components, and/or do not articulate as designed should
be disposed of.
If applicable, return the instruments to the appropriate locations in the surgical tray. The BioHorizons Prosthetics Tray, Small
should be cleaned and sterilized empty. For sterilization, place the cleaned device in an approved sterilization bag or wrap and
run through one of the following qualified sterilization cycles:
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