S4 Occipital Cervical Thoracic System

Safety notes Aesculap® S4 Occipital Cervical Thoracic System Intended use The S4 Occipital Cervical Thoracic System implants are used for the dorsal monosegmental and multisegmental stabilization of the occipitocervical junction and of the cervical and upper thoracic spine. The system consists of: ■ Occiput plates ■ Rods ■ Mini polyaxial screws ■ Set screws ■ Hook ■ Cross connector ■ Other connectors Appropriate implant components from S4 SPINE System® (e.g. rods) can also be used. Special instruments must be used for implanting these components, as well as for the distraction, compression and reduction of the lumbar and thoracic spine.

Materials The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ISO5832-3 ■ ISOTAN®P pure titanium acc. to ISO 5832-2 The titanium implants are anodized with a colored oxide layer. Slight changes in coloration may occur, but do not affect the implant quality. ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany.

CAUTION Federal law restricts this device to sale by, or on order of a physician! ■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly. ■ General risk factors associated with surgical procedures are not described in in the present instructions for use. ■ The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the established operating techniques. ■ The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood vessels, muscles, and tendons. ■ The operating surgeon is responsible for combining and implanting the implant components, with or without bone cement. ■ It is the operating surgeon's responsibility to ensure the correct combination of implant components and their implantation. ■ Aesculap is not responsible for any complications arising from wrong indication, wrong choice of implant, incorrect combination of implant components and operating technique, the limitations of the treatment method, or inadequate asepsis. ■ The instructions for use for individual Aesculap implant components must be followed. ■ The implant components were tested and approved in combination with Aesculap components. If other combinations are used, the responsibility for such action lies with the operating surgeon. ■ Do not, under any circumstances, combine implant components from different manufacturers. ■ Do not, under any circumstances, use damaged or surgically removed components. ■ Implants that have been used before must not be reused. ■ Damage to load-bearing bone structures can result in loosening of the components, bone or implant fractures or other acute complications. ■ To ensure the earliest possible detection of such implant dysfunction, the prosthetic joint must be checked periodically, using appropriate techniques. The implant 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. Scanning a patient who has this implant may result in patient injury. WARNING

Indications Use for: ■ Fractures ■ Degenerative instability ■ Post-trauma instability ■ Tumors

■ Delayed healing can cause implant breakage due to material fatigue. ■ The attending physician shall make any decision with regard to the removal of implant components that have been used.

■ Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migration, and other severe complications.

■ The implant components applied, along with their article numbers, the name of the implant, as well as the batch number and serial number (if available) must be documented in all patient records.

Contraindications Do not use in the presence of: ■ Fever ■ Acute or chronic vertebral infections of a local or systemic nature ■ Pregnancy ■ Severe osteoporosis or osteopenia ■ Medical or surgical conditions that could negatively affect the outcome of the implantation ■ Mental illness ■ Dependency on pharmaceutical drugs, drug abuse, or alcoholism ■ Adiposity ■ Severely damaged bone structures that could prevent stable implantation of implant components ■ Neuromuscular disorders or illnesses ■ Bone tumors in the region of implant fixation ■ Wound healing disorders ■ Inadequate patient compliance ■ Foreign body sensitivity to the implant materials ■ Cases not listed under indications

Side effects and interactions The application or improper use of this system entails the following risks: ■ Implant failure resulting from excessive load – Warping or bending – Loosening – Breakage ■ Inadequate fixation ■ Failed or delayed fusion ■ Infection ■ Fractured vertebral body or bodies ■ Injuries to – Nerve roots – Spinal cord – Blood vessels – Organs

■ Postoperatively, individual patient information, as well as mobility and muscle training, is of particular importance.

Sterility ■ The implant components are supplied in an unsterile condition. ■ The implant components are packaged individually. ► Store the implant components in their original packaging and only remove them from their original and protec-

tive packaging immediately prior to application. ► Use the implant system storage unit for sterilization and sterile prep.

Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the following validated reprocessing procedure: ► Validated sterilization process – Steam sterilization using fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

Validated reprocessing procedure Sterilization ► Validated sterilization process

– Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer: ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.