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Double Angle Reconstruction Plate Mandible Introduction, Features, Benefits, Indications, Precautions, Warnings and Surgical Technique.

The aim of surgical fracture treatment with Double Angle Reconstruction Plate Mandible 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.

Double Angle Reconstruction Plate Mandible

Double Angle Reconstruction Plate Mandible Features and Benefits

  • Wide offering of Double Angle Reconstruction 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.

Double Angle Reconstruction Plate Mandible Indications

Plates are intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region
of the mandible and fractures of the condylar basis region of the mandible.

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Double Angle Reconstruction Plate Mandible Surgical Technique

Expose and reduce fracture

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

Select and prepare implant

Select the appropriate plate depending on the indication. Orient the plate so the topside is facing out.

Cut to length, if necessary. Mini and intermediate plates may be cut using the combination bending/cutting pliers. Large plates may be cut using the shortcut plate cutters.

Determine the appropriate screw type.

Contour the plate

Contour the plate to match the anatomy. An exact match is not required when using locking screws, because plate stability is not dependent on plate-to-bone contact when screws are locked.

Plates can be contoured using the combination bending/cutting pliers and combination bending pliers.

Position the plate

Place the plate over the fracture or osteotomy site. Use the plate holding forceps to secure the plate to the bone, if desired.

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

Insert the proper length locking or nonlocking screw through the plate 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 previously outlined procedure. Securely tighten all screws unless resection is to follow.

Resect the mandible

Once the plate is in place, remove the plate and screws, taking note of each screw’s placement.

Resect the mandible.

Replace the implants

Place the plate back onto the mandible in its original position. Reinsert each predetermined screw. Check all screws to ensure a secure fit in the plate.

Apply bone graft

A vascularized bone graft must be applied to constructs used in reconstructing the mandible.

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Double Angle Reconstruction Plate Mandible 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 Double Angle Reconstruction Plate Mandible.

Warnings and Precautionary for Angle Reconstruction Plate Mandible

Before using Angle Reconstruction Plate Mandible, 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.

Angle Reconstruction 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  implants 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 plates, 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 Angle Reconstruction Plate Mandible.
  • Mechanical failure of the implant, including bending, loosening or breakage.
  • Migration of implant resulting in injury.

Preoperative Planning for Angle Reconstruction Plate Mandible

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 Angle Reconstruction Plate Mandible 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.

Angle Reconstruction Plate Mandible 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 this Angle Reconstruction 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.

Angle Reconstruction Plate Mandible Warnings

  • Angle Reconstruction Plate Mandible 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. Implants removal should be followed by adequate post-operative management to avoid refracture.

Angle Reconstruction Plate Mandible 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 Angle Reconstruction Plate Mandible, reoperation.

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