CARE IMPLANTS & INSTRUMENTS
Description
| S.No. | Ref No. | Hole |
| 1 | CM6500.009 | 9 Hole |
| 2 | CM6500.014 | 14 Hole |
Micro H-Plate Features and Benefits
- Wide offering of Micro H-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.
Micro H-Plate 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.
Micro H-Plate 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 Micro H-Plate
Before using Micro H-Plate, 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.
Micro H-Plate is made from medical grade materials and are designed, constructed and produced with utmost care. These quality Micro H-Plate 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 Micro H-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 Micro H-Plate.
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 Micro H-Plate, 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 Micro H-Plate.
- Mechanical failure of the implant, including bending, loosening or breakage.
- Migration of implant resulting in injury.
Preoperative Planning for Micro H-Plate
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 Micro H-Plate must be available.
The clinician should discuss with the patient the possible risks and complications associated with the use of Micro H-Plate. 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.
Micro H-Plate 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 screw.
- 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.
Micro H-Plate Warnings
- Micro H-Plate 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. Implant removal should be followed by adequate post-operative management to avoid refracture.
Micro H-Plate 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 implant, reoperation.
