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Orbital Plate Craniomaxillofacial Introduction, Features, Benefits, Indications, Precautions, Warnings and Surgical Technique.

The aim of surgical fracture treatment with Orbital Plate Craniomaxillofacial is to reconstruct the bony anatomy and restore its function. According to the AO, internal fixation is distinguished by anatomical reduction, stable fixation, preservation of blood supply, and early, active mobilization.

Orbital Plate Craniomaxillofacial

Orbital Plate Craniomaxillofacial Features and Benefits

  • Wide offering of Orbital Plate geometries, sizes, and strengths
  • Seven screw diameters to choose from: 1.5 mm, 2 mm, 2.5 mm, 2.8 mm, 2 mm Locking, 2.5 mm Locking and 2.8 mm Locking
  • Rounded edges on plates for less irritation to soft tissue, where applicable
  • Reduced plate/screw profile, where applicable
  • Emergency screws available for each screw diameter
  • Plates and Screws are made from pure Titanium
  • Standardized instrumentation
  • locking plate increases construct stability, decreases risk of screw back-out and subsequent loss of reduction. It also reduces the need for precise anatomic plate contouring and minimizes the risk of stripped screw holes.

Orbital Plate Craniomaxillofacial Indications

Plate is intended for use in selective trauma of the midface and craniofacial skeleton, craniofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla and chin.

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Orbital Plate Craniomaxillofacial Surgical Technique

Expose and reduce fracture

After completing the preoperative plan, expose the fracture or osteotomy site. In trauma reduce the fracture as required.

Select and prepare the implant

Select the appropriate plate for the nature of the fracture. Orient the plate so that the topside is facing out. Cut to length, if necessary.

Contour the plate

Contour the plate to fit to the patient anatomy using the bending pliers. Ensure the plate is passively adapted to the bone.

Position the plate

Place the plate over the fracture or osteotomy site.

Drill the hole

Predrilling is recommended in complex fractures of the midface and in regions with thick cortical bone. Drill the first hole close to the fracture or osteotomy site.

Screw insertion

To engage the screw on the blade, align the blade over the cruciform recess and slowly rotate it counter-clockwise until the blade drops into the recess; firmly press the blade to fully seat it into the screw. A half counter-clockwise rotation of the engaged screwdriver facilitates the screw removal from the clip.

Insert the first screw close to the fracture or osteotomy site, and tighten until secure.

Insert the second screw on the opposite side of the fracture or osteotomy site, and then all remaining screws following the outlined procedure.

If the screw is inserted with angulation, verify that the screw is safely retained in the plate hole and that the construct profile is not significantly increased.

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Orbital Plate Craniomaxillofacial Contraindications

Contraindications may be qualified or total, and need to be taken into consideration when evaluating the prognosis in each case. The physician’s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment. Conditions presenting an increased risk of failure include:

  • Any active or suspected latent infection or marked local inflammation in or about the affected area.
  • Compromised vascularity that would inhibit adequate blood supply to the fracture or the operative site.
  • Bone stock compromised by disease, infection or prior implantation that can not provide adequate support and/or fixation of the devices.
  • Material sensitivity, documented or suspected.
  • Obesity. An overweight or obese patient can produce loads on the implant that can lead to failure of the fixation of the device or to
    failure of the device itself.
  • Patients having inadequate tissue coverage over the operative site.
  • Implant utilization that would interfere with anatomical structures or physiological performance.
  • Any mental or neuromuscular disorder which would create an unacceptable risk of fixation failure or complications in postoperative care.
  • Other medical or surgical conditions which would preclude the potential benefit of surgery.
  • All associated diseases which could endanger the function and success of the Orbital Plate Craniomaxillofacial.

Warnings and Precautionary for Orbital Plate Craniomaxillofacial

Before using Orbital Plate Craniomaxillofacial, the surgeon and ancillary staff should study the safety information in these instructions, as well as any product-specific information in the product description, surgical procedures and/or brochures.

Orbital Plate is made from medical grade materials and are designed, constructed and produced with utmost care. These quality plates assure best working results provided they are used in the proper manner. Therefore, the following instructions for use and safety recommendations must be observed.

Improper use of  Orbital Plate can lead to damage to the tissue, premature wear, destruction of the instruments and injury to the operator, patients or other persons.

It is vital for the operating surgeon to take an active role in the medical management of their patients. The surgeon should thoroughly understand all aspects of the surgical procedure and instruments including their limitations. Care in appropriate selection and proper use of surgical instruments is the responsibility of the surgeon and the surgical team. Adequate surgical training should be completed before use of implants.

Factors which could impair the success of the operation:

  • Allergies to implanted materials.
  • Localized bone tumours.
  • Osteoporosis or osteomalacia.
  • System disease and metabolic disturbances.
  • Alcohol and drug abuse.
  • Physical activities involving excessive shocks, whereby the implant is exposed to blows and/or excessive loading.
  • Patients who are mentally unable to understand and comply with the doctor’s instructions.
  • Poor general health.

Possible Adverse Effects

The following adverse effects are the most common resulting from implantation:

  • Loosening of the implants, which may result from cyclic loading of the fixation site and/or tissue reaction of the implant.
  • Early and late infection.
  • Further bone fracture resulting from unusual stress or weakened bone substance.
  • Temporary or chronic neural damage resulting from pressure or hematomata.
  • Wound hematomas and delayed wound healing.
  • Vascular disease including venal thrombosis, pulmonary embolism and cardiac arrest.
  • Heterotopic ossification.
  • Pain and discomfort due to presence of the Orbital Plate Craniomaxillofacial.
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for Orbital Plate Craniomaxillofacial

The operating planning is carried out following a thorough clinical evaluation of the patient, Also, x-rays must be taken to allow a clear indication of the bony anatomy and associated deformities. At the time of the operation, the corresponding implantation instruments in addition to a complete size of Orbital Plate Craniomaxillofacial must be available.

The clinician should discuss with the patient the possible risks and complications associated with the use of implants. It is important to determine pre-operatively whether the patient is allergic to any of the implant materials. Also, the patient needs to be informed that the performance of the device cannot be guaranteed as complications can affect the life expectancy of the device.

Orbital Plate Craniomaxillofacial Precautions

  • Confirm functionality of instruments and check for wear during reprocessing. Replace worn or damaged instruments prior to use.
  • It is recommended to use the instruments identified for Orbital Plate.
  • Handle devices with care and dispose worn bone cutting instruments in a sharps container.
  • Always irrigate and apply suction for removal of debris potentially generated during implantation or removal.

Orbital Plate Craniomaxillofacial Warnings

  • Orbital Plate Craniomaxillofacial can break during use (when subjected to excessive forces). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part should be removed. Be aware that implants are not as strong as native bone. Implants subjected to substantial loads may fail.
  • Instruments, screws and cut plates may have sharp edges or moving joints that may pinch or tear user’s glove or skin.
  • Take care to remove all fragments that are not fixated during the surgery.
  • While the surgeon must make the final decision on implant removal, we recommend that whenever possible and practical for the individual patient, fixation devices should be removed once their service as an aid to healing is accomplished. Orbital Plate removal should be followed by adequate post-operative management to avoid refracture.

Orbital Plate Craniomaxillofacial General Adverse Events

As with all major surgical procedures, risks, side effects and adverse events can occur. While many possible reactions may occur, some of the most common include: Problems resulting from anesthesia and patient positioning (e.g. nausea, vomiting, dental injuries, neurological impairments, etc.), thrombosis, embolism, infection, nerve and/or tooth root damage or injury of other critical structures including blood vessels, excessive bleeding, damage to soft tissues incl. swelling, abnormal scar formation, functional impairment of the musculoskeletal system, pain, discomfort or abnormal sensation due to the presence of the device, allergy or hypersensitivity reactions, side effects associated with hardware prominence, loosening, bending, or breakage of the device, mal-union, non-union or delayed union which may lead to breakage of the Orbital Plate Craniomaxillofacial, reoperation.

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