Manufacturer

Paonan Biotech Co.,Ltd

3F,No.50,Lane.258,Rueiguang Road, Neihu Chiu,Taipei 114,Taiwan

Patented, all rights reserved

UFO Intervertebral Spacer

Cervical

Surgical Procedure

UFO

1

Contents

Introduction

Implants

Instruments

Surgical Technique Steps

Important Information

www.biomech-spine.com

Paonan Biotech Co., Ltd

3F, No, 50, Lane, 258, Rueiguang Road,

Neihu Chiu, Taipei 114, Taiwan

Patented, all right reserved

DC Medical, S. L.

C/Aguacate, 41-Edifioio B, Portal 3

Planta 2a-Local 2, 28044 Madrid

Tel:+34 91 400 68 44

Surgical Technique

UFO Cervical

Introduction

The UFO cervical dynamic intervertebral spacer is

positioned somewhere in between the traditional

fusion cage and artificial disc. It can effectively

restore the disc height and provide the cervical

vertebrae appropriate mobility. With the properties of

the materials applied, the stability of the fusion cage

and the motion preservation of the artificial disc can

be well integrated.

The elasticity of the UFO can evenly share the

loading and damping during the activity of human

body.And the porous surface treatment of the titanium

alloy dome can further increase the initial and long

term stability after implantation.

Indications

UFO is indicated and clinically proven for :

- HNP C3-4 to C7-T1.

- Cervical spondylosis.

- Cervical radiculopathy.

- Degenerative cervical disc disease.

- Cervical myelopathy.

- MRI documented evidence of mechanical pressure

on neurological elements.

- Single or multiple level spinal canal compression

from C3-4 to C7-T1.

Contraindications

- Severe osteoporosis

- Active infection of the involved vertebral bodies

- Sensitivity to implant materials

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Surgical Technique

UFO Cervical

Implants

- Simple implantation

- Dynamic function

- Stresses decentralization

- Press fit the disc space

- Initial stability obtained

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REF Width (W) Length (L) Height (H)

4100-05

4100-06

4100-07

4100-08

15 mm

15 mm

15 mm

15 mm

14 mm

14 mm

14 mm

14 mm

5 mm

6 mm

7 mm

8 mm

Silicone + Ti

Surgical Technique

UFO Cervical

Instruments

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Photo Cat.No. Description Q'ty

218-0625 Trial #5 1 pcs

218-0626 Trial #6 1 pcs

218-0627 Trial #7 1 pcs

218-0628 Trial #8 1 pcs

410-0204 Curette * optional order

410-0105 Impactor 1pcs

202-3402 Retractor

* optional order(202-

3402, 202-3403 and

202-3404 are one set)

202-3403Fixation Screw/Pin

(12mm)

202-3404Fixation Screw/Pin

Driver

410-0109 Reamer 5.5 1 pcs

Surgical Technique

UFO Cervical

Surgical Technique Steps

Implantation of the UFO in 4 Stages:

1. Initial Approach & Discectomy

2. Trial Insertion and sizing

3. Endplate Dome Preparation

4. Implantation

Easy Surgery

Easy implantation, similar surgical technique to the one for Cervical

fusion cage. Initial stability can be achieved through the fit in place of the

upper and lower dome.

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Surgical Technique

UFO Cervical

Surgical Technique Steps

1. Initial Approach & Discectomy

Discectomy and preparation of the surgical site

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Don‘t need to remove anterior caudal tip

Surgical Technique

UFO Cervical

2. Trial Insertion and sizing

Placing the trial implant for Check size of the implants

Selecting UFO size by UFO Trial (218-0625~8) to find its proper size to confirm it

wont‘t come out easily. If the Trial can be pick out easily, retracting the Carspar

Retractor (202-3402) and removed Trial until it meets correct size. .

Surgical Technique Steps

UFO Trials

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Surgical Technique

UFO Cervical

Surgical Technique Steps

3. Endplate Dome preparation

- Release Carspar Retractor (202-3402)

- Insert Reamer (410-0109) into disc space. Keep “v” ditch of Reamer Head align middle

line of vertebral body under radiographic examination.

Notice: 1. Bolt line is the reference aligning vertebrae edge

2. Thin line is the reference borderline of UFO implant

- Compress Carspar Retractor (202-3402) and utilize Reamer (410-0109) to make 2

concaves in depth of 2.75mm each for convex dome to fix into UFO on endplate. Bigger

and deeper concave is all right but cannot be smaller or shallow in height. The middle line

is minor concern.

-Meanwhile, the upper and lower dome after implantation can be also fixed into

subchondral bone for effective bone fusion and increased intervertebral stability.

Reamer for concave space

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Surgical Technique

UFO Cervical

Thin line

Bolt line

4. Implantation

Take UFO Implant (same size as the trial) held by Impactor (410-0105) to insert implant into

the space. Verify implant position by Radiographic image then removed Impactor (410-0105)

and remove Carspar Retractor (202-3402) secondarily.

Surgical Technique Steps

UFO Impactor

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Surgical Technique

UFO Cervical

Final CheckingAfter removing Carspar Retractor (202-3402), confirm the tightness of implant UFO in vertebra

gently, make sure it won’t be slide out in its proper size and final check UFO position by

Radiographic Image.

Surgical Technique Steps

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Flexion Extension

Surgical Technique

UFO Cervical

WOUND CLOSURE

1. If needed, the diaphragm is repaired prior to routine muscle

closure Drains are used on the nstructions of the surgeons.

2. Remove all instruments and carefully checked to ensure

nothing is left inside the patient.

3. The wound is subsequently closed in the routine manner.

POSTOPERATIVE MANAGEMENT

1. Patient may be allowed to sit in bed with back support 1-3

days after the operation.

2. Wound drains are removed 48 hours after the operation.

3. If the patient is able to be ambulated with or without

crutches, he is allowed to do so 5 days after the operation.

4. Respiratory therapy, particularly during the first 3 days after

operation, for expansion of the lungs is recommended.

5. Patients should be instructed to wear a spinal collar for 1– 2

months following surgery.

POSTSCRIPT

The above description is only the standard installing

procedure of the Trend® Intervertebral Spacer System.

Since every patient’s physiological condition is different, the

surgeon should take detail examination and careful judgment

before surgery, so that the operation will go through smoothly

and the

patient may also recover earlier.

INSTRUCTIONS FOR PATIENT

1. The patient must be aware of all postoperative restrictions,

particularly limitations related to cupational and sports

activities .

2. The patient should be warned that non-compliance with the

postoperative instructions may lead to failure of the implant.

Additional surgery may also be required to remove the device.

Precautions to Patients:

1. Although the use of internal fixation implants has given the

surgeons a mean of bone fixation and help

generally in the management of fracture and re-constructive

surgery , these implants are only intended to be a temporary

device to assist normal healing and are not intended to

replace normal body

structures. Bone fixation devices are internal splints which

provide a means of bone fixation while normal bone healing

occurs.

2. Postoperative care is extremely important. The patient must

be instructed in the limitations of this implant and must be

warned regarding weight-bearing and body stress on the

device prior to firm bone healing. The patient should be

warned that non-compliance with postoperative instructions

could lead to failure of the device and the possible need

thereafter for additional surgery to remove the device.

Precautions to Surgeons:

1. The Trend® Intervertebral Spacer System should not be used

to span more than three segments.

2. The surgeons must be thoroughly knowledgeable of the

mechanical

3. The patient should be adequately instructed. Postoperatively

care and the patient’s ability and willingness to follow instructions

are one of the most important aspects of successful bone

healing. The patient must be made aware of the limitations of the

implant, and that physical activity and full weight bearing have

been implicated in premature failure of internal fixation devices.

The patient should be made aware that an implant is not as

strong as normal, healthy bone and will fracture if excessive

demands are placed on it in the absence of complete bone

healing. An over- active, debilitated or demented patient who

cannot properly use weight-supporting devices may be

particularly at risk during postoperative rehabilitation.

4. Removal of the implant after healing: Implants can be loosen,

fracture, corrode, migrate, possibly increase the risk of infection,

cause pain or stress shield bone even after healing, particular in

young, active patients. The surgeons should carefully weigh the

risks versus benefits when deciding whether to remove the

implant . Implant removal should be followed by adequate

postoperative management to avoid re-fracture. If the patient is

older and has a low actively level, the surgeon may choose not to

remove the implant, thus eliminating the risks involved with a 2nd

surgery.

5. Until firm bony union (confirmed by clinical and radiographic

examination) is established, the patient should employ

adequate external support and restrict physical activities which

would place excessive stresses upon the implant or allow

movement and delay or prevent healing.

Possible Adverse Effects:

The following are specific adverse effects which should be

understood by the surgeon and explained to

the patient. These do not include all adverse effects which can

occur with surgery in general, but are important considerations

particular to internal fixation devices. General surgical risks

should be explained to the patient prior to surgery.

. Infection

. Pain, discomfort or abnormal sensations due to presence of the

device.

. Sensitivity or allergic reaction to a foreign body.

. Bending or fracture of the implant; loosening of the implant

. Decrease in bone density due to stress shielding

. Bursitis

Warnings:

The above information is provided by the manufacturer as an

educational material for the surgeon in understanding the product

and other related knowledge. However, the procedure used in

each patient should be based on his (her) individual circumstance

under the professional judgment of the operating surgeon with

sound planning prior to the implant operation.

Important Information

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Surgical Technique

UFO Cervical