What Summary Of Safety And Clinical Performance? - ZhongXing

This Summary of Safety and Clinical Performance (SSCP) is intended to provide public access to an updated summary of the main aspects of the safety and clinical performance of the device.

The SSCP is not intended to replace the Instructions For Use as the main document to ensure the safe use of the device,nor is it intended to provide diagnostic or therapeutic suggestions to intended users or patients.

The following information is intended for users/healthcare professionals.

If the SSCP includes a patients, the following can be added: Following this information there is a summary intended for patients.

  1. 1. Deviceidentification and general information
  2. 1. Device trade name (s)

Posterior cervical fixation system

1.2.  Manufacturer’s name and address

Manufacturer’s name:Beijing Chunlizhengda Medical Instruments Co., Ltd. Manufacturer’s address:No. 10 Xinmi West 2nd Road, South Region of  Tongzhou Economic Development Zone, Tongzhou District, Beijing, 101112, China

1.3.  Manufacture’s single registration number (SRN)

SRN:CN-MF-000019514

1.4.  Basic-UDI-DI

Please refer to 22-CL-CE-2-001-0004 Basic-UDI-DI of the Posterior cervical fixation system.

1.5.  Medical device nomenclature description / text

EMDN code and description

Code P09070301

Official term  SPINE STABILISATION PROSTHESES AND SYSTEMS

1.6.  Class of device

Class IIb, according to Annex VIII of the MDR.

1.7.  Year when the first certificate (CE) was issued covering the device

Chunlizhengda has received CE marking for anterior cervical fixation system under Directive 93/42/EEC in 2020 year

1.8.  Authorized representative if applicable; name and the SRN

Name:MedNet EC-REP C III GmbH

SRN:DE-AR-000011196

1.9.  NB’s name (the NB that will validate the SSCP) and the NB’s single identification number

Name:TÜV SÜD Product Service GmbH

Identification Number:0123

  1. 2. Intendeduse of the device

2.1.  Intended purpose

The Posterior Cervical Fixation System contains two series. The fixation system is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The Posterior Cervical Fixation System consists of a variety of shapes and sizes of plates, rods, crosslink (Connected Plate/ Connecting hook), screws, hook, side joints and set screw.

2.2.  Indication(s) and target population(s)

Indications:

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

2) Spondylolisthesis;

3) Spinal stenosis;

4) Fracture/dislocation;

5) Atlanto /axial fracture with instability;

6) Occipitocervical dislocation;

7) Revision of previous spine surgery;

8) Tumors

2.3.  Contraindications and/or limitations

Contraindications include, but are not limited to:

The selection of the proper size, shape and design of the implant for each patient is crucial to the success of the procedure. The following of listing of potential adverse events includes:

  1. Active infectious process or significant risk of infection (immunocompromise).
  2. Signs of local inflammation.
  3. Fever or leukocytosis.
  4. Morbid obesity.
  5. Mental illness.
  6. Grossly distorted anatomy caused by congenital abnormalities.
  7. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
  8. Suspected or documented metal allergy or intolerance.
  9. Any case not needing a bone graft and fusion.
  10. Any case where the implant components selected for use would be too large or too small to achieve a successful result.
  11. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
  12. Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
  13. Any patient unwilling to follow postoperative instructions.

15.Any case not described in the indications.

  1. Device description

3.1.  Description of the device

The Posterior Cervical Fixation System contains two series. The fixation system is intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), which are used to fix the anterior cervical vertebrae of patients.

The devices are provided in non-sterile. It is required to be sterilized via autoclave  method to reach a SAL of 10-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1:2006 Sterilization of health care products -- Moist heat--Part 1:Requirements for the development, validation, and routine control of a sterilization process for medical devices.

3.2.  A reference to previous generation(s) or variants if such exist, and a description of the differences

Not applicable. There is no previous generation.

3.3.  Description of any accessories which are intended to be used in combination with the device

Not applicable. There are no accessories for this device.

3.4.  Description of any other devices and products which are intended to be used in combination with the device

Not applicable. Device is not intended to be used in combination with any other devices and products.

  1. 4. Risksand Warnings

4.1.  Residual risks and undesirable effects

A comprehensive analysis of all the residual risk has been done by the review team. Considering combined  effect of all individual residual risks, the final  conclusion  is drawn that  the product comprehensive residual risk can be accepted. The detailed assessments are listed as follows:

1)   Are individual risk controls in contradiction?

Conclusion: No risk controls have yet been found in contradiction.

2)    Review of the instructions (e.g. is there any contradictory description? Is there any rule difficult to follow? )

Conclusion: The product instructions comply with requirements of related regulation. Descriptions related to the product are clear and easy to understand.

3)    Comparison with similar products

Conclusion: Compared with similar devices on the market in clinic, properties and performances aspects. The products performance are similar to these devices. Therefore they are judged to have comparable properties to these device.

  • Conclusion ofthe review team

Conclusion: The final conclusion has been reached through the above assessments that the product comprehensive residual risk can be accepted.

4.2.  Warnings and precautions

Warnings:

The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of this device for any other conditions are unknown. The implants are not prostheses. In the absence of fusion, the instrumentation and/or one or more of its components can be expected to pull out, bend or fracture as a result of exposure to every day mechanical stresses.

Precautions

  1. Surgeon should be skilled in the operation of equipment and implants, a better experience in spinal surgery;
  2. The doctor should evaluate the patient before surgery, and judge whether it is suitable for using the implants according to the patient's weight, occupation, activity intensity, mental condition, whether it is allergic to foreign body, and the course of the disease; the applicable model specifications should be selected according to the patient's own situation. Before the operation, the implants of different types and specifications must be prepared, and surgery must not be performed without adequate preoperative preparation;
  3. If the implant is broken, displaced, fractured, loose, infection or bone loss, the implant should be considered for removal.
  4. The implant shall not be processed or altered in any way except as permitted by design and as specified in the technical manual. Avoid correcting, bending, cutting or scratching the implants to prevent its failure.
  5. Patients should undergo postoperative restrictive activities under the guidance of a doctor to prevent product failure and complications caused by excessive activity or weight bearing after surgery.
  6. Patients and their families should be aware of postoperative complications and possible side effects.
  7. The expiration date of this product: one year after implantation in the human body or as directed by the doctor.

4.3.  Other relevant aspects of safety, including a summary of any field safety corrective action (FSCA including FSN) if applicable

Not applicable


Post time: Apr-26-2024

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