Securespan

Safety notes 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.

Aesculap® Securespan® WARNING

Intended use The Securespan® system implants are used for laminoplasty procedures of the cervical and upper thoracic spine. They comprise:

■ 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.

System component

∅ [mm]

Lengths [mm]

Use

■ The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-

Single bend plate

-

4, 6, 8, 10, 12

Providing fixation of the laminar gap

■ The operating surgeon is responsible for combining and implanting the implant components, with or without

Self-drilling/tapping laminoplasty screws

2.0

4, 5, 6, 8, 10, 12

Fixing the plate to lateral mass or lamina

■ It is the operating surgeon's responsibility to ensure the correct combination of implant components and their

Self-tapping revision screws

2.4

5, 6, 7, 9, 11, 13

Rescuing holes

Self-tapping stabilization block fixation screw

2.0

sels, muscles, and tendons. bone cement. 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.

Attaching the stabilization block to the plate

■ 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.

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

Indications The Securespan® laminoplasty-plating system is intended for use in the cervical and upper thoracic spine (C3–T3) after a laminoplasty has been performed. The Securespan® system is designed to keep the stabilization block in place in order to prevent the stabilization block from expulsion or impinging on the spinal chord. Surgically installed implants serve to support the normal healing process. They are not supposed to replace normal body structures or to support permanent loads that occur in cases where healing does not occur. Securespan® implants should always be used with a stabilization block (by e.g. a bone graft).

Contraindications Do not use in the presence of: ■ Fever ■ Acute or chronic vertebral infections of a local or systemic nature ■ Pregnancy ■ Acute osteopenia ■ Severe osteoporosis or osteopenia ■ Medical or surgical conditions that could negatively affect the outcome of the implantation ■ Severely damaged bone structures that could prevent stable implantation of implant components ■ Systemic or metabolic disease ■ Neuromuscular disorders or illnesses ■ Foreign body sensitivity to the implant materials ■ For screw attachment or fixation to the posterior elements of the Lumbar Spine ■ For single or two-level spondylosis without developmental spinal canal stenosis ■ Under any direct load bearing conditions ■ Isolated radiculopathy ■ Loss of anterior column support resulting from tumor, trauma, or infection ■ Focal anterior compression ■ 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 ■ Injuries to – nerve roots – spinal cord – blood vessels – organs ■ Stabilization block resorption (if bone graft is used) ■ Tissue reaction to implant materials ■ Reduced joint mobility and flexibility ■ Arthralgia and reduced tolerance for exercise

■ Do not, under any circumstances, combine implant components from different manufacturers. ■ The Securespan® system should always be used with a stabilization block. ■ Do not, under any circumstances, use damaged or surgically removed components. ■ Implants that have been used before must not be reused. ■ The attending physician shall make any decision with regard to the removal of implant components that have been used.

■ 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.

■ Delayed healing can cause implant breakage due to material fatigue. ■ In order to promote the earliest possible detection of any problems or complications, the operation results must be followed up at regular intervals with the aid of appropriate examination procedures. A precise diagnosis requires x-rays taken in the directions anterior-posterior and medial-lateral.

■ At the time of follow-up exams, the scope of postoperative load and aftercare should be determined for each

patient on the basis of their weight, their activities, the type and severity of the fracture, and any coexisting injuries. Also, the dimensions of the implant should be taken into account.

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

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 Sterilization should always be favored over disinfection under all circumstances. Only if final sterilization is not possible should disinfection with a virucidal agent be preferred. Note For the latest information on 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

Application

Mechanical alkaline cleaning and thermal disinfection ► Place the implants on a tray that is suitable for cleaning (avoiding rinsing blind spots). ► Connect components with lumens and canals directly to the special rinsing port of the injector cart. Keep working

ends open during cleaning. Place the product on the tray with all product links and joints open. Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

I

Prerinse

<25/77

II

Cleaning

55/131

t [min]

Water quality

Chemical/Note

3

D–W

-

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

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

WARNING

The operating surgeon shall devise an operation plan that specifies and accurately documents the following: ■ Selection of the implant components and their dimensions ■ Positioning of the implant components in the bone ■ Location of intraoperative landmarks The following conditions must be fulfilled prior to application: ■ All requisite implant components are ready to hand. ■ Operating conditions are highly aseptic. ■ All requisite implantation instruments must be available and in working order, including specialized Aesculap implantation systems. ■ The operating surgeon and operating room team are thoroughly familiar with the operating technique and with the available range of implants and instruments; information materials on these subjects must be complete and ready to hand. ■ The operating surgeon is fully conversant with the rules governing medical practice, the current state of scientific knowledge, and the contents of relevant scientific articles by medical authors. ■ The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the area operated on. The surgical procedure and following information has been explained to the patient, and the patient's consent has been documented: ■ Special instrument set provided for sizing and implantation of the Securespan® laminoplasty system. ■ Corrective surgery may become necessary if the implant loosens. ■ The patient must undergo medical follow-up examinations of the prosthetic joint at regular intervals. Implantation of the Securespan® system implant requires the following steps: ► Perform open door laminoplasty procedure from a standard posterior approach. ► Use provided trials to get the proper size stabilization block. ► Select appropriate sized plate and stabilization block and assemble together with the stabilization block fixation screw. ► Place assembled plate/screw/block into open gap and fix with appropriate length screws.

WARNING

Incorrect application can result in trauma to the spinal cord and nerve roots! ► Select the appropriate size Securespan® system plate length and screw length according to the individual indication, preoperative planning and bone situation found intraoperatively.

WARNING

Take extreme care not to damage soft tissue/neural structures during implantation. ► To avoid tearing out the screws from the bone, or damaging the screws or plates, never over tighten.

Risk of injury due to drilling too deep! ► Always drill with the aid of intraoperative x-ray. WARNING ► To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant compo-

nents.

WARNING

► 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.

Sterilization

Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

Risk of injury due to insufficient clamping force provided by the stabilization block fixation screw. ► Position the correctly sized stabilization block into the created gap. ► Tighten the stabilization block fixation screw to secure the stabilization block.

Risk of injury due to screw breakage! ► Keep screwdriver on the screw axis while picking up and inserting screws. Do not bend. WARNING

► 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.

Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

CAUTION

Damage to or breakage of the Securespan® caused by excessive strain on the material! ► Always bend the Securespan® plate in one direction only. ► Do not bend back the Securespan® plate.

Note Implant removal can give rise to complications due to implants that are stuck, ingrown bone tissue, etc. Such complications can lead to damage to implants and/or instruments. For such cases we recommend using a set of special instruments, which can be ordered from Aesculap. This instrument set should be at hand for every explantation. Other special instruments are available for dealing with broken implants. Note the instructions for use for such case! Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate B. Braun/Aesculap office.

Disposal ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging.

TA-Nr. 013082

2017-12

V6

Änd.-Nr. 57595