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The Cervical BMD Titanium ACIF Implant ®

The Cervical BMD Titanium ACIF Implant ®
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The Cervical BMD Titanium ACIF Implant ®

Product catalog summary
Overview: This document serves as a surgical technique guide for the Cervical BMD Titanium ACIF Implant, detailing the procedure, implant specifications, and usage considerations for spinal fusion surgeries.
Patient Positioning: The patient should be positioned supine with the head fixed to maintain cervical spine lordosis. A radiolucent table is recommended for X-ray verification of disc and implant positioning.
Installation of the Caspar Distractor: Distraction pins are placed in the vertebral body adjacent to the disc, using the Caspar Distractor to restore disc height and access the intervertebral space.
Discectomy: Complete removal of the intervertebral disc and cartilaginous endplates is required to expose bony endplates for implant stability.
Determination of Implant Size: A trial implant is chosen based on intervertebral space dimensions and patient anatomy, with X-ray confirmation of its position.
Implant Installation: The implant is mounted on the Implant Holder and inserted into the intervertebral space, with X-ray used to confirm proper positioning.
Implant Removal: The Inserter or Universal Removal Instrument is used for careful implant removal to prevent posterior displacement.
Implant Specifications: Various sizes and angles of ACIF implants are listed, each with specific part numbers.
Tool List: A detailed list of required tools is provided, including curettes, cage holders, and trial implants.
Device Description and Materials: The implants are made from biocompatible titanium with a grid structure to enhance stability and bioactivity, promoting bone formation and reducing non-union risk.
Indications and Contraindications: Indicated for cervical interbody fusion in degenerative and traumatic disc cases. Contraindications include infection, obesity, and certain bone conditions.
Warnings and Precautions: Correct placement and size selection are critical. Additional fixation may be needed, and the procedure should be performed by experienced surgeons. Risks include implant migration, breakage, and non-fusion.
Potential Adverse Effects: Possible adverse effects include implant breakage, migration, nerve damage, infections, and non-fusion.
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Catalog excerpts

The Cervical BMD Titanium ACIF Implant ®-1

The Cervical BMD Titanium ACIF Implant ® Surgical Technique Guide

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The Cervical BMD Titanium ACIF Implant ®-2

BMD Titanium ACIF Implant BMD Titanium ACIF GW Implant BMD Titanium PLIF Implant BMD Titanium TLIF Implant BMD Titanium PLIF GW Implant BMD Titanium XLIF Implant BMD Titanium ALIF Implant 3D-printed spinal fusion Global BMD Titanium Implants® The Cervical BMD Titanium ACIF Implant ®—Surgical Technique Guid

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The Cervical BMD Titanium ACIF Implant ®-3

Positioning of the patient 4 Installation of the Caspar Distractor Discectomy 5 Determination of Implant Size 5 Implant Installation 6 Termination of the procedure 6 Implant Removal 6 List of implants 7 Tool list 8 Important information on the Global Titanium ACIF Implants The following general Surgical Technique Guide is for illustrative purposes only. As with all surgical procedures, the technique used in each case will depend on the surgeon’s medical judgment as to the best treatment for each patient. Only those individuals with specialized training and experience in spinal surgery should...

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The Cervical BMD Titanium ACIF Implant ®-4

Figure 1 Patient positioning Figure 3 Distraction of operative level Installation of the Caspar Distractor The patient is positioned on his back and the head is fixed. Cervical spine should be in physiological lordotic position. The incision should target the area of the operation. Expose the intervertebral disc and the adjacent vertebral body with a standard anterior approach to cervical spine (Figure 1). The incision should enable relevant access for the stabilisation of the spine segment. A radiolucent operating table is recommended, as X-ray shall be used to confirm identification of the...

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The Cervical BMD Titanium ACIF Implant ®-5

Figure 4 Perform a complete discectomy Figure 5 Trial selection Determination of Implant Size To ensure smooth assembly, fair stability and fast fusion after the implantation, it is necessary to remove the full intervertebral disc including the cartilaginous endplates and expose the bleeding bony endplates (Figure 4). Selection of the trial implant depends on the height, width and depth of intervertebral space and the way of patient preparation and anatomy (Figure 5). Make sure that the side with appropriate lordosis is selected before inserting Use X-Ray to check the correct position of the...

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The Cervical BMD Titanium ACIF Implant ®-6

Figure 6 Mount the selected implant Figure 8 Implant removal Implant installation Implant removal Open the sterile packaging of the implant size that was determined with the Trial implant.Mount the selected implant on the Implant Holder and tighten with hand (Figure 6). Make sure that locking pins, which determine the implant position are correctly positioned before tightening the Implant Holder. Either the Inserter or Universal Removal Instrument may be used for Implant removal by attachment via clockwise rotation to the implant threads (Figure 8). Be careful to avoid pushing the implant posteriorly....

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The Cervical BMD Titanium ACIF Implant ®-7

List of implants DESCRIPTION, D x H x W, PART NUMBER PART NUMBER PART NUMBER

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The Cervical BMD Titanium ACIF Implant ®-8

Tool list DESCRIPTION, D x W x H, Spoon Curette Open Curette Cage Holder Cage Holder with Stopper Final Impactor Caspar Right Pins Holder Pin for Caspar 14mm Pin for Caspar 16mm Caspar Left ACIF Trial 0°, 10 x 12 x 4 mm ACIF Trial 0°, 10 x 12 x 5 mm ACIF Trial 0°, 10 x 12 x 6 mm ACIF Trial 0°, 10 x 12 x 7 mm ACIF Trial 0°, 10 x 12 x 8 mm ACIF Trial 0°, 10 x 12 x 9 mm ACIF Trial 0°, 12 x 14 x 4 mm ACIF Trial 0°, 12 x 14 x 5 mm ACIF Trial 0°, 12 x 14 x 6 mm ACIF Trial 0°, 12 x 14 x 7 mm ACIF Trial 0°, 12 x 14 x 8 mm ACIF Trial 0°, 12 x 14 x 9 mm ACIF Trial 0°, 14 x 16 x 4 mm ACIF Trial 0°, 14 x...

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The Cervical BMD Titanium ACIF Implant ®-9

Important information on the Global BMD Titanium Implant ® Device Description and Materials Global Biomedica offers spinal surgery implants with excellent biocompatibility and bioactivity. We use the latest innovative technologies to create a line of spinal BMD Titanium Implant ®. These are implant for interbody fusion of biocompatible titanium (Ti64ELI). Internal and surface grid structure with optimum pore size of 700µm (Cube vertex centroid - lattice) with reinforced edges ensures not only high stability and resistance to deformation of the implant, or immersion in the vertebral body, but...

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The Cervical BMD Titanium ACIF Implant ®-10

The effectiveness and safety of interbody fusion is only applicable for certain conditions with significant instability which require the fusion supported by medical device. Correct placement and appropriate size selection are crucial to achieve optimal results. The device might be supportive for such mechanical instability like deformity, fracture, listhesis, dislocation, tumor, pseudoarthrosis. The effectiveness and safety for any other conditions are unknown. Potential Adverse Effects Potential adverse events which may occur after the spinal surgery with or without instrumentation include,...

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The Cervical BMD Titanium ACIF Implant ®-11

Disclaimer: This document is intended exclusively for physicians and is not intended for laypersons. Information on the products and procedures contained in this document is recommendations. Because this information does not purport to constitute any diagnostics or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Caution: Please see the product Instructions for Use for a complete listing of the indications, contraindications,...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.