3.5 mm Locking Plate Calcaneal, Right/Left Contraindications
Contraindications may be qualified or total, and need to be taken into consideration when evaluating the prognosis in each case. Alternative management techniques may need to be considered under the following conditions:
- Acute or chronic infections, either local or systemic.
- Local or systemic accurate or chronic inflammation.
- Serve muscular, nervous or vascular disease endangering the affected area.
- Defective bone structures, which would impede adequate anchoring of the implant.
- All associated diseases which could endanger the function and success of the implant.
Warnings and Precautionary for 3.5 mm Locking Plate Calcaneal, Right/Left
Before using 3.5 mm Locking Plate Calcaneal, Right/Left, 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.
Plates are made from medical grade materials and are designed, constructed and produced with utmost care. These quality 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 Plates 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 3.5 mm Locking Plate Calcaneal, Right/Left.
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 3.5 mm Locking Plate Calcaneal, Right/Left, 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 Implants.
- Mechanical failure of the implant, including bending, loosening or breakage.
- Migration of implant resulting in injury.
Preoperative Planning for 3.5 mm Locking Calcaneal Plates
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 set of 3.5 mm Locking Plate Calcaneal, Right/Left 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.
