Apfelbaum screws for anterior odontoid screw fixation

■ 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.

Aesculap® Apfelbaum screws for anterior odontoid screw fixation

■ 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.

■ Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-

Intended use

tance.

The implant is used ■ for the anterior stabilization of Anderson-D’Alonzo type II odontoid fractures and depending on the type III fracture line ■ for posterior C1/C2 articular screw fixation for osseous fusion Dimensions of the Apfelbaum screws: ■ Diameter of 4.0 mm ■ Lengths ranging from: 32-64 mm ■ Thread length: Full or partial thread

■ Use Apfelbaum screws only with the instruments that are designed especially for the Apfelbaum system. ■ Do not combine titanium implants with components made of implant steel.

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 processing. ► Use the implant system storage devices for processing, sterilization and sterile setup. ► Ensure that the implant components in their implant system storage devices do not come into contact with each

Materials The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ISO 5832-3 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.

Indications Use for: ■ Fresh Anderson-D’Alonzo type II odontoid fractures and depending on the type III fracture line ■ Trans-articular C1/C2 screw fixation in the presence of atlanto-axial instability

Contraindications Do not use in the presence of: ■ Fever ■ Infection: systemic or localized in the spine ■ Pregnancy ■ Medical or surgical conditions that could negatively affect the outcome of the implantation ■ Foreign body sensitivity to the implant materials ■ Acute osteopenia ■ Severe osteoporosis or similar loss of bone density ■ Severe damage to the osseous structures preventing fixation of the implant components ■ Bone tumors in the region of implant fixation ■ Anticipated overloading of the implant ■ Systemic or metabolic diseases ■ Dependency on pharmaceutical drugs, drug abuse, or alcoholism ■ Morbid obesity (adiposity) ■ Generally poor condition of the patient ■ Inadequate patient compliance ■ Cases not listed under indications

other or with instruments. ► Ensure that the implant components are not damaged in any way.

Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the following validated reprocessing procedure: Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Validated reprocessing procedure Mechanical alkaline cleaning and thermal disinfection ► Place the implants on a tray that is suitable for cleaning (avoiding rinsing blind spots).

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

Side effects and interactions

I

Prerinse

<25/77

3

D–W

-

Implant failure resulting from excessive load: ■ Warping or bending ■ Loosening ■ Breakage ■ Inadequate fixation ■ Failed or delayed fusion ■ Infection ■ Spondylolisthesis ■ Delayed healing, or non-union and development of pseudarthrosis ■ Incorrect implant position ■ Bone graft resorption ■ Deterioration of the atlanto-occipital joints Injuries to: ■ Dura ■ The vertebral arteries ■ Nerve roots ■ Spinal cord ■ Blood vessels ■ Organs ■ Tissue reaction to the implant materials ■ Reduced joint mobility and flexibility ■ Arthralgia and reduced tolerance for exercise

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline For implant components that are to be resterilized:

WARNING

Safety notes 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 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. ■ 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. 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

WARNING

Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable for resterilization! ► Handle the implants with new gloves only. ► Keep the implant system storage devices covered or closed. ► Process implant system storage devices separately from instrument trays. ► Clean implants must not be processed together with contaminated implants. ► Process the implant components individually and separately if no implant system storage devices are available, ensuring that the implant components are not damaged in the process. ► Mechanically clean and disinfect the implant components. ► Do not reuse surgically contaminated implants! Direct or indirect contamination may render implants unsuitable for resterilization! ► Do not reprocess implants that have been directly or indirectly contaminated with blood.

Inspection, maintenance and checks ► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► Immediately set aside damaged or inoperative products.

Packaging ► Place the product in its holder or on a suitable tray. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Make sure that the packaging will prevent a recontamination of the product during storage.