piranha - file.spinalelements.com · the piranha acp has been designed with a sagittal and axial...

CERVICALFIXATION

ANTERIOR CERVICAL PLATEPIRANHASURGICAL TECHNIQUE GUIDE

Disclaimer:The surgical technique shown is for illustrative purposes only. The technique(s) actually employed in each case will always depend upon the medical judgment of the surgeon before and during surgery as to the best mode of treatment for each patient. Please reference the 510K or package insert for additional information and a complete list of intended indications, warnings, precautions, and other medical information.

1755 West Oak Parkway Marietta, GA 30062

Phone: 877-755-3329Fax: [email protected]

PIRANHASurgical Technique Guide

Table of Contents

Features & Benefits..........................................................................3

Implant & Instrument Guide............................................................4-8

Surgical Technique Guide.............................................................9-15

Indications/Contraindications/Warnings/Precautions...................16-19

3

Features & Benefits

It’s Both Thin And RobustThe Piranha Anterior Cervical Plate features a thin 2.2mm profile with large graft windows to enhance visualization and minimize tissue damage. The Piranha is anatomically designed with a small degree of lordosis and enhanced load sharing to promote fusion. The Piranha’s unique locking mechanism provides tactile feedback and minimizes the possibility of screw loosening.

• Implant grade Titanium Alloy (Ti 6Al-4V ELI) construction• Low profile plate (2.2mm)• Max plate width: 16.6mm• Large graft windows• Lordosed plate design• Available in 1, 2, 3 and 4 level plates from 10-95mm lengths• Self-drilling variable and fixed screws in 12, 14, and 16mm lengths• 4.0mm standard and 4.25mm rescue screws available• 16º cephalad/caudal screw angle with variable screws• Color coded screws based on diameter, lengths, and fixed/variable head identification

Features and Benefits

4

Implant &Instrument Guide

5

Implant & Instrument Guide

ImplantsPlates

*Not included in standard tray configuration.

Part # Level and Length Qty/Tray

P1-0010* 1 Level 10mm

P1-0012 1 Level 12mm 2

P1-0014 1 Level 14mm 2

P1-0016 1 Level 16mm 2

P1-0018 1 Level 18mm 2

P1-0020 1 Level 20mm 2

P1-0022 1 Level 22mm 2

P1-0024 1 Level 24mm 2

P2-0024* 2 Level 24mm

P2-0026 2 Level 26mm 2

P2-0028 2 Level 28mm 2

P2-0030 2 Level 30mm 2

P2-0032 2 Level 32mm 2

P2-0035 2 Level 35mm 2

P2-0038 2 Level 38mm 2

P2-0041 2 Level 41mm 2

P2-0044 2 Level 44mm 2

P2-0047 2 Level 47mm 2

Part # Level and Length Qty/Tray

P3-0046 3 Level 46mm 1

P3-0049 3 Level 49mm 1

P3-0052 3 Level 52mm 1

P3-0055 3 Level 55mm 1

P3-0058 3 Level 58mm 1

P3-0061 3 Level 61mm 1

P3-0064 3 Level 64mm 1

P3-0067 3 Level 67mm 1

P4-0055* 4 Level 55mm

P4-0058* 4 Level 58mm

P4-0060 4 Level 60mm 1

P4-0065 4 Level 65mm 1

P4-0070 4 Level 70mm 1

P4-0075 4 Level 75mm 1

P4-0080 4 Level 80mm 1

P4-0085 4 Level 85mm 1

P4-0090 4 Level 90mm 1

P4-0095 4 Level 95mm 1

6


Trays

Screws

18mm and extra sharp variable screws available

Part # Description Qty/Tray

CP5000 Piranha Set Tray 1

CP5011 1 Level Caddy 1




CP5017 Screw Caddy 1

Part # Description Qty/Tray

CSV-40-12 Variable Screw, 4.0 x 12mm 12



CSV-425-12 Rescue Variable Screw, 4.25 x 12mm 6



CSF-40-12 Fixed Screw, 4.0 x 12mm 12



CSF-425-12 Rescue Fixed Screw, 4.25 x 12mm 6



CP10020 Temporary Fixation Pin 6

7


Instruments

Plate Bender CP10001

QTY/Tray: 1

Drill GuideCP10006

QTY/Tray: 1

Plate HolderCP10008

QTY/Tray: 1

Mini Ratchet HandleCP10011

QTY/Tray: 1

8


Bone AwlCP10050

QTY/Tray: 1

2.5mm Hex Screw Driver (Stab & Grab Tip)CP10017.SGQTY/Tray: 2

Plate Shield DriverCP10022

QTY/Tray: 1

Instruments

12mm Hand DrillCP10002

QTY/Tray: 1


QTY/Tray: 1


QTY/Tray: 1

12mm Drill BitCP10013

QTY/Tray: 1


QTY/Tray: 1


QTY/Tray: 1

9

Surgical Technique Guide

10

..

The Piranha ACP has been designed with a sagittal and axial contour to better fit the normal cervical anatomy. If additional lordosis is desired, this may be obtained utilizing the Plate Bender (CP10001). The plate is placed between the bending tabs and with single hand compression additional lordosis is obtained. Do not bend the plate in the proximity of the screw holes.

Note: Inspect the plate to ensure the locking shield mechanisms are intact prior to insertion. Do not reversebend the Piranha ACP as this may weaken the plate. Repeated bending will cause the titanium plate to weaken. Discard the plate if repeated or reverse bending of the plate is required as this may lead to eventual breakage of the plate.

The patient is placed in a supine position with the cervical spine in slight extension. Anterior approach is made via a transverse incision in the skin folds for one or two level fusion. Additional levels may be approached via an oblique incision along the anterior border of the sternocleidomastoid.

The anterior cervical spine is exposed via blunt fascial dissection. After discectomy or corpectomy, a bone graft or PEEK implant is then inserted.

Select the appropriate Piranha Anterior Cervical Plate. The distance between the cephalad and caudad holes can be measured with a caliper and corresponds to the appropriate length plate. If the measurement falls between the length of two plates, it is recommended to choose the smaller plate to avoid interference with the adjacent disc space.


Plate Bender


Patient Positioning

Plate Selection

11


Temporary Fixation Pins

Plate HolderOnce the appropriate length plate is determined, place the plate into position on the vertebrae using the provided Plate Holder (CP10008).

The plate is then placed in the appropriate position and may be held with non-implantable Temporary Fixation Pins (CP10020). Two pins may be placed for rotational stability. Ensure that Fixation Pins are removed before completing the case.

12

Screw hole preparation may be performed utilizing a Drill Guide or Awl. The technique utilized must correspond to the bone screw inserted.

The Drill Guide (CP10006) must be seated firmly in the plate prior to preparation of the screw hole. The cannula of the Drill Guide was designed with a shoulder and spherical surface to match the plate.

Note: Over-angulation of the Drill Guide should be avoided as this may affect the screw-plate locking mechanism.

Drilling may be performed utilizing the Hand Drills (CP10002, CP10003, CP10004) or by connecting the Mini Ratchet Handle (CP10011) to the Drill Bits (CP10013, CP10014, CP10016). The drills correspond to the screw lengths available.


Screw Hole Preparation

Drill Guides

Drills


13

Once the screw hole has been prepared, select the appropriate screw. Insert the Screw Driver (CP10017.SG) hex into the screw, and advance the screw into the bone and plate screw hole until it passes by the locking shield. A tactile or audio click may be heard. A provisional x-ray may be obtained prior to final seating to ensure adequate placement of the screws. Remove the Screw Driver from the screw. Once all screws have been inserted, rotate the Plate Shield Driver (CP10022) 90 degrees in either direction to lock or unlock screws. Locking should be ensured by confirming that the lateral edges of the locking shields are positioned over the proximal shoulders of the bone screws.

Another option for screw hole preparation is the Awl (CP10050). Once fully seated in the plate screw hole, the self-centering Awl is used to pierce the anterior cortex of the vertebral body and create a pilot hole. After removing the Awl, the screw holes can be drilled or simply insert the screws (self-drilling) into the hole which has been created.


Screw Insertion

Awl

14

Indications/Contraindications/Warnings/Precautions

INDICATIONS

The Piranha Anterior Cervical Plate is indicated for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion in the treatment of the following:

• Degenerative disc disease (DDD) – defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies

• Spondylolisthesis• Spinal Stenosis• Tumors• Trauma (i.e. fracture)

CONTRAINDICATIONS

The Piranha Anterior Cervical Plate System is not designated or sold for any use except as indicated. DO NOT USE IMPLANTS IN THE PRESENCE OF ANY CONTRAINDICATION.

Contraindications include, but are not limited to:• Presence of overt infection and/or localized inflammation or foci or infections.• Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis.• Suspected or documented metal allergy or intolerance.• Any patient having inadequate tissue coverage over the operative site.• Any time implant utilization would interfere with anatomical structures or expedited physiological performance, such as

impinging on vital structures.• Severe comminuted fractures such that segments may not be maintained in satisfactory proximate reduction.• Use in displaced, non-reduced fractures with bone loss.• The presence of marked bone absorption or severe metabolic bone disease that could compromise the fixation achieved.• Any other medical or surgical condition which would preclude the potential benefit of surgery, such as elevation of

sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), fever, leukocytosis or a marked left shift in the WBC differential count.

• The physical contact of the Piranha Anterior Cervical Plate System implants with metal implant made of anything other than implant grade titanium, such as stainless steel (ASTM F138) or other dissimilar metal.

• Situations with the absence or compromise of significant stabilizing elements.• Use in the presence of any neural or vascular deficits or other compromising pathology, which may be further injured by

device intervention.

15


WARNINGS

Potential risks identified with the use of this device system, which may require additional surgery, include:

• Device component fracture• Loss of fixation• Non-union• Fracture of the vertebra• Neurological injury• Vascular or visceral injury

This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

PRECAUTIONS

• THE IMPLANTATION OF SPINAL FIXATION DEVICES SHOULD BE PERFORMED ONLY BY EXPERIENCED SURGEONS WITH A SPECIFIC TRAINING IN THE USE OF SUCH DEVICES. THIS IS A TECHNICALLY DEMANDING PROCEDURE PRESENTING A RISK OF SERIOUS INJURY TO THE PATIENT.

• CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of the metal implants should only be done with proper equipment. It is recommended that contouring be gradual and that great care be used to avoid any notching, scratching, or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant.

• REMOVAL OF THE IMPLANT AFTER HEALING. Metallic implants can loosen, fracture, corrode, migrate, possibly increase the risk of infection, cause pain, or stress shield bone even after healing, particularly in young, active patients. The surgeon should carefully weigh the risk versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risk involved with a second surgery.

• ADEQUATELY INSTRUCT THE PATIENT. Postoperative 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 follow the postoperative care regimen as instructed by his or her physician.

The Piranha Anterior Cervical Plate System should be implanted only by surgeons who are completely experienced with the implantation of such devices and the required specialized spinal techniques. The Piranha Anterior Cervical Plate System is only a temporary implant used for the correction and stabilization of the cervical spine. A successful result is not achieved in every surgical case. Bone grafting must be part of the spinal fusion procedure in which the system is used.

Reoperation to remove or replace implants may be required at any time due to medical reason or device failure. If corrective action is not taken, complications may occur.

These complications may include, but are not limited to:• Device corrosion with localized tissue reaction and pain.• Device migration which may result in injury to soft tissue, visceral organs or joints.• Loosening or disassembly of implant resulting in additional injury.• Bending, loosening, or breaking of the implant making removal difficult, impractical or impossible.• Abnormal sensations, discomfort or pain.• Increased risk of infection.• Bone loss due to stress shielding.

16


PRECAUTIONS (continued)

Preoperative and operating procedures including knowledge of surgical techniques, good reduction, and proper selection and placement of the implant are important considerations in the successful utilization of the Piranha Anterior Cervical Plate System.

Proper patient selection and the patient’s ability to comply with physician instructions and follow prescribed treatment regimen will greatly affect the results. It is important to screen patients and select optimal therapy given physical and/or mental activity requirements and/or limitations. If a surgical candidate exhibits any contraindication or is predisposed to anycontraindication, DO NOT USE the Piranha Anterior Cervical Plate System.

Patients who smoke have shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Patients with poor bone quality are also poor candidates for surgery.

The selection of patients for internal fixation requires consideration of the following to ensure the success of the procedure:• Patient’s vocation or activity: If the patient’s lifestyle includes physical activities such as running, lifting, muscle strain, or

excessive walking, the consequential forces can cause failure of the implant.• Patient’s weight: An overweight patient can produce burden on the implant that can lead to failure of the implant.• Patient’s mental condition: Various conditions that may cause the patient to ignore certain necessary limitations and

precautions in the use of the implant, leading to failure or other complications include, but are not limited to: senility, mental illness, alcoholism.

• Patient’s susceptibility to adverse conditions as a result of having a foreign material implanted in their body.

OMNI-MM-103 Rev. 0

1755 West Oak ParkwayMarietta, GA 30062

Phone: (877) 755-3329Fax: (877) [email protected]

piranha - file.spinalelements.com · the piranha acp has been designed with a sagittal and axial...

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