The Lumbar BMD Titanium TLIF Implant ® Surgical Technique Guide

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 Lumbar BMD Titanium TLIF Implant ®—Surgical Technique Guid

Preparation and Approach 4 Decompression and Discectomy 4 Distraction 5 Determination of Implant Size 5 Implant Insertion 6 Completion of Surgery 6 Implant Removal 7 List of implants 8 Tool list 9 Important information on the BMD Titanium TLIF Implant ® 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 attempt to use the BMD...

Figure 1 Patient positioning Figure 2 Endplate preparation The patient is placed on the OR table using the standard positioning in cases of Posterior Lumbar Interbody Fusion (Figure 1). Make sure the ab domen is free positioned to avoid pressure on the large vessels and to minimize blood loss. A radiolucent OR table is recommended, as X-ray shall be used to confirm identification of the affected disc and in a later stage the position of the implant. Mark the affected segment after fluoroscopy control. A standard incision is performed over the level(s) to be instrumented. Expose the spinous process...

Figure 3 Intervertebral disc space Figure 5 Determination the implant size Determination of Implant Size An adequate distraction of the intervertebral disc space is one of the preconditions for the primary stability required after implant implantation. For this purpose Distractors are available in several heights (Figure 3). Each size of Distractor has grooves, that indicate the length of 26, 30 and 34 mm respectively. It should be considered to start with the smallest size Distractor to avoid over distraction. Apply the Distractor parallel to the intevertebral space and turn clockwise to open...

Figure 6 Implant mounting Figure 8 Moving the implant Implant insertion Open the sterile packaging of the implant size that was determined with the Trial. After Implantation of the implant a final check of the position of the implant under fluososcopy is advised (Figure 9). Posterior supplemental fixation is strongly recommended. Perform wound closure as usual. Please document which implants were used in the patient files. Patient labels are supplied with each implant for your convenience. The use of the BMD Titanium TLIF Implant ® does not require any specific postoperative care and the patient...

Figure 10 Implant removal Implant Removal Either the Inserter or Universal Removal Instrument may be used for Implant removal by attachment via clockwise rotation to the implant threads (Figure 10). Be careful to avoid pushing the implant posteriorly. Once the implant is firmly attached, remove the implant from the disc space. Vertebral bone overgrowth or osteophytes may beremoved to facilitate implant retrieval. The Lumbar BMD Titanium TLIF Implant ®—Surgical Technique Guide

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

Tool list DESCRIPTION D x W x H, Distractor 7 Distractor 8 Distractor 9 Distractor 10 Distractor 11 Distractor 12 Distractor 13 Distractor 14 Distractor 15 Curette D9L5 Curette 45° D9L5 Curette 15° D5L3 Curette 15° D9L5 T-Handle Mallet Rasp Distractor 16 Distractor 17 Trial Basket Cage Holder Hook TLIF Trial 4° 1/4, 26 x 12 x 07 mm TLIF Trial 4° 1/4, 26 x 12 x 08 mm TLIF Trial 4° 1/4, 26 x 12 x 09 mm TLIF Trial 4° 1/4, 26 x 12 x 10 mm TLIF Trial 4° 1/4, 26 x 12 x 11 mm TLIF Trial 4° 1/4, 26 x 12 x 12 mm TLIF Trial 4° 1/4, 26 x 12 x 13 mm TLIF Trial 4° 1/4, 26 x 12 x 14 mm TLIF Trial 4° 1/4, 26...

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...

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,...

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,...