product risk management report for spine products

Product Risk Management Report KH/JS-CE-JZ03 B/2

PRODUCT RISK MANAGEMENT REPORT FOR SPINE PRODUCTS 1 Foreword

In accordance with MDD, 93/42/EEC（Amended by 2007/47/EC）, and Medical devices – Application of risk management to medical devices, each potential hazard in clinical application of sterile bone screws produced by the company is analyzed, its origin identified in this section. The severity of harm and the probability of occurrence of each hazard are estimated. Once a risk becomes unacceptable, its reduction measures are taken, in the meanwhile the subsequent evaluation of the residual risk is conducted. At last all the residual risks are evaluated. The results of the above work show that the level of overall residual risks is acceptable to ensure that our products are safe and effective, and can be placed on the market. 2 Scope of Application

Products with CE mark and manufactured by our company. 3 References 3.1 Normative standards

ISO 14971 Medical devices – Application of risk management to medical devices ISO 5832-1 Implants for surgery—Metal material—stainless steel processing materials ISO 5832-2 Implants for surgery—Metal material—pure titanium

ISO 5832-3 Implants for surgery—Metal material—Ti - 6 aluminium vanadium alloy material 4

ISO/TR 14283 Implants for surgery—Fundamental principles ISO 14630 Non-active surgical implants – General requirements ISO14602 Non-active surgical implants-Implants for osteosynthesis-Particular requirements

ASTM F 1717 Standard test method for spinal implant structure in vertebrectomy ISO 15730 Metallic and other inorganic coating- electropolishing as a means of smoothing

and passivating stainless steel ASTM F 86 Standard Practice for Surface Preparation and Marking of Metallic Surgical

Implants ASTM A 380 Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and System ASTM A 967 Standard Specification for Chemical Passivation Treatment for Stainless Steel Parts ASTM B 600 Standard Guide for Descaling and Cleaning Titanium and Titanium Alloy Surfaces ASTM D 4169 With its transport containers system performance testing standard operating

procedures 3.2 Referenced data —AO ASIF Spine internal fixation V1 M.Aebi、J.S.Thalgott、J.K.Webb Director

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DangGenDing、LiuZhongJun、ChenCuQiang Director 2000,July. People’s Medical Publishing House V1

—Spinal Internal Fixation V1 [USA]Howard S.An、Jerome M.Cotler LvHouShan Director 2001,Feb.China Medical Science Press

—Spine Surgery II Director: Rao Shucheng Sep.2000 People’s Medical Publishing

House—Spine Invasive Surgery I Director: Jia Lianshun&Li Jiashun May.2000 Shanghai FarEast Press

—Spine Surgery II Director:KeithH.Briduell&Rouald L.Dewald Translate by :Hu Yougu, Dang Gengting, Tang Tiansi Nov.2000 People’s Medical

Publishing House —Master Techniques in Orthopaedics Surgery- Spine I Translated by Zhang Yonggang,

Wang Yan Audited by Lu Shibi Jan. 2003 LiaoNing Science and Technology Publishing House

4 Group of risk analysis

Name Position and duty in company Position in group Wang Zhimin DGM leader Jiang Decheng Technical Consulter member

Ma Haomin Manager, Technical Dept. member Ma Haomin Manager, Technical Dept. member

Jiang Qingxing Chief Engineer member Cao Hua Manager, Quality Dept. member

Wu Zhengqian Manager, Logistics Dept. member Wang Tong Manager, marketable Dept. member

Huang Feipeng Manager, Sale Dept. member Xu Li Attending Doctor member

5 Product Description 5.1 General description The subject of this risk management report is spinal products. According to different assembling way of spinal implants, it can be divided into two fixation systems: plate and screw; screw,rod,block and hook.According to 4 principles of internal fixation AO*.The surgeons with spinal operation knowledge and experience do the reduction and fixation for patients’ surgery area. patients can maintain the surgical site in the state three-dimensional spine fusion, this fixation method in the international orthopedic treatment has been widely used.

* 4 principles AO: (1) reconstruction of anatomy through reduction and fixation of bone fracture; (2) reconstruction stability by fixation or splinting in accordance with the “personality” of bone fracture and the need of a trauma; (3) protection of soft tissues and blood supply of bone through careful operations and delicate reduction and (4) early and safe,

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local and systemic motion training. 5.2 Function instruction of the product

Spinal implant design protects nerve function, maintain sequence, reduce deformity (the same as spinal scolosis and kyphos), provide mechanism maintains to extreme so as to recover in early time and maintain spine stable till the accomplishment of fusion. 5.3 Environment for use Spine implants are supplied to medical institutions for therapeutically qualified and experienced surgeons to use in operating rooms for the treatment of patients. 5.4 Information and data related to risk assessment In addition to Section 3 References in this report, the following documents are referenced:

- Type Test Report on Sterile Bone Screws - Test report of biocompatibility for surgical implants

6.Implementation of Risk Management Process It is well known that the concept of risk is comprised of two elements:

--The Probability of occurrence of harm, i.e. the frequency of harm to take place. --The consequence of harm, i.e. the severity of harm.

The company has conducted risk analysis and management of sterile bone screws in accordance with the requirements of ISO 14971.

6.1 Intended purpose and identification of qualitative and quantitative characteristics related to the safety of the medical device

Pre requirements of Annex C, ISO 14971, the company listed a question table below to identify characteristics that could impact on safety of spinal products Table 1 Questions to identify sterile spinal product characteristics that could impact on safety No. Questions Identification of impact on safety

1 What is the intended use and how to use

1.1 What is the intended use for the medical device?

Spinal implants are used to fix after patients’ reduction so as to help fusion under the normal spine physiological structure

1.2 How to use the medical device?

Spinal products are selected by orthopedists and used with associate instrument to treat patient with bone fracture.

1.3

What role of medical devices is expected to play in the diagnosis, prevention, care, treatment or mitigation, trauma and disability compensation, replacement or correction of anatomy and other aspects?

Products are expected to reset the patient’s spine ,to make spine reduction and fixation in the vertebral and pedicle ,in order to maintain the normal anatomy of spine to make sure the normal (non deformity) recovery

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1.4 What are indications for use (e.g. patient population)?

Cervical and thoracolumbar surgery for spine scolosis, tumor, kyphose,stenosis,slippage,fracture

1.5 Does the medical device sustain or support life? Not Applicable (hereinafter NA)

1.6 Is special intervention necessary in the case of failure of the medical device?

The implant should be taken out of patients or considered by surgeons do some remedial measures when products lose its effect (loose/broken).

Continued Table 1 Questions to identify sterile spinal product characteristics that could impact on safety

No. Questions Identification of impact on safety

2 Is the medical device intended to be implanted?

Yes. The product is to be used by orthopaedics surgeons and patients. Surgeons should be under special technical training. The operations should be in special operation room. The surgery should be undergoing when patient is general anesthesia status. Patients’ movement after surgery will affect instruments’ usage

3 Is the medical device intended to be contact the patient or other persons?

Yes. The product is intended to be implanted into the patient body and permanently contacts him.

4

What materials or components are utilized in the medical device or are used with, or are in contact with, the medical device?

Yes. The materials which are used to make bone screws are recommended by AO and specified by ISO standards, i.e. stainless steel ,pure titanium and titanium alloy for surgical implants. Their biological performance and mechanical properties are well known by the medical society. However, attention is to be paid to avoid implantation of different metals together in surgery, which may results in corrosion and finally failure of the implants.

5 It energy delivered to or extracted from the patient? Not Applicable (hereinafter NA)

6 Are substances delivered to or extracted from the patient? Not Applicable (hereinafter NA)

7

Are biological materials processed by the medical device for subsequent re-use, transfusion or transplantation?

Not Applicable (hereinafter NA)

8

Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?

Yes. The products manufactured by our company are supplied in sterile condition. Before using ,the products can be sterilize by operators.

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9 Is the medical device intended to be routinely cleaned and disinfected by the user?

Yes. The products supplied in sterile condition by this company .Before using ,the products can be cleaned am sterilized by operators.

10 Is the medical device intended to modify the patient environment?


11 Are measurements taken? Not Applicable (hereinafter NA)

12 Is the medical device interpretative? Not Applicable (hereinafter NA)

13

Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies?


14 Are there unwanted outputs of energy or substances? Not Applicable (hereinafter NA)

15 Is the medical device susceptible to environmental influences?


16 Does the medical device influence the environment? Not Applicable (hereinafter NA)

17 Are there essential consumables or accessories associated with the medical device?


18 Is maintenance or calibration necessary? Not Applicable (hereinafter NA)

19 Does the medical device contain software? Not Applicable (hereinafter NA)

20 Does the medical device have a restricted shelf-life?

Not Applicable (hereinafter NA). The product is suggested takeing out after 8~36 months, the detailed time see AOOrthopaedics Internal Fixation P295.

21 Are there any delayed or long-term use effects?

Yes. The product is used in human body for long time, and it does not need to be taken out if still be available.

22 To what mechanical forces will the medical device be subjected?

Yes. The implant partially bears the patient body weight and other mechanical forces when he changes his position.

Continued Table 1 Questions to identify sterile spinal product characteristics that could impact on safety No. Questions Identification of impact on safety

23 What determines the lifetime of the mechanical device?

Yes. The life time of the product depends upon the position of insertion ,the time and the weight of the patient and if the patient take activities according to the doctors’ advice after inserting the body of patient

24 Is the medical device intended for single use?

Yes. The product is intended for single use and reuse is not allowed.

25 Is safe decommissioning or disposal of the medical device necessary?


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26 Does installation or use of the medical device require special training or special skills?

Yes. It is not allowed for unskillful and not well trained persons to implant spinal products into patient body.

27 How will information for safe use be provided?

Yes. It is provided from instruction for use of spinal products.

28 Will new manufacturing processes need to be established or introduced?


29 Is successful application of the medical device critically dependent on human factors such as the user interface?

Yes. Successful use of implants depends on the operators (orthopedic doctor's) clinical experience, whether operators can insert implant rightly by using surgical instruments according to the disease of patient The success of implant use also depends on the preoperative physical, whether of metal allergy, whether asked to comply with doctor's surgery and other factors (such as patients with non-mechanical force is expected to produce games, resulting in implant breakage) .

29.1 Can the user interface design features contribute to use error?


29.2 Is the medical device used in an environment where distraction can cause use error?


29.3 Does the medical device have connecting parts or accessories?

Yes. In clinics, spine implants should be used together with screw, plate, rod, hook and block. There are connection part, which should keep stability when premium use.

29.4 Does the medical device have a control interface? NA

29.5 Does the medical device display information? NA

29.6 Is the medical device controlled by a menu? NA

29.7 Will the medical device be used by persons with special needs?

Yes. It is not allowed for unskillful and not well trained persons to implant this product into patient body, mainly used for patients of fixed fracture.

29.8 Can the user interface be used to initiate user actions? NA

30 Does the medical device use an alarm system? NA

31 In what way(s) might the medical device be deliberately misused?

NA

32 Does the medical device hold data critical to patient care? NA

33 Is the medical device intended NA

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to be mobile or portable?

34 Does the use of the medical device depend on essential performance?

NA

35 In what way(s) might the medical device be deliberately misused?

35.1

Is there a biocompatibility problem related with improper selection of raw materials for implants?

No. The implant material of this company is chosen according to the recommendation of AO Orthopaedics Internal Fixation. There are material of stainless steel, pure titanium and titanium alloy. All chemical components are in accordance with the regulation for ISO5832-1, ISO5832-2, ISO5832-3, so there will be no problem of biocompability.

35.2

Is mal-operation in the process of lathing (planning, milling) an element attributing to implant failure?

Yes. Misuse material produce biocompatible problems. There will be potential corrosion if use improper material, which affect the service time , cause the product lose efficacy.

35.3

Can improper design of the product result in the fracture of the implant in clinical use?

Yes. The spinal implant design of this company is referred to the similar products. There is relative company standard which regulate product material, specification, size and technical characteristics, so that can make design risk into lowest.

35.4 Potential risks in product manufacturing processes

35.4.1

Are there any factors that cause products lose the efficacy because of improper operation arise from the milling, polishing process of the product?

Yes. During the machining process ,can produce burr and affected by oil, if removing the burr is not clear ,after inserting the body ,may produce potential corrosion ,then produce the final fracture of products and residual risk because of not clear cleaning

35.4.2

Can improper polishing result in fracture of the implant?

Yes. Improper polishing will result in micro-burs which will react with body fluid, cause corrosion, shorten the life-span of implant, and, in most serious case, fracture of the implant will take place.

35.4.3

Is there a biocompatibility problem of the product in polishing course?

Yes. The product is contaminated with polishing grease. Improper cleaning and wash will affect the cleanliness of the product and its biocompatibility.

35.4.4

May biocompatible problems occur after cleaning prior to sterile packing?

Yes. This company uses the solution with cleaning agents with coconut acid amides as the main components ,after removing oil ,polishing compound ,cleaning with fresh water, exist detergent residue composition, thus produce biological compatibility problems

35.4 May electric polishing process Yes. Take electric polishing for products in order to

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.5 become a cause of product fracture?

remover micro-burs ,if the solution take a long time ,will reduce the size of products, seriously ,will produce the fracture of implants.

35.4.6

Does improper rinse process following electric polishing affect biocompatibility of the product?

Yes. In electric polishing the employed electrolyte is an acid solution. Improper rinse may result in electrolyte residual on implant surface, thus affect its biocompatibility.

35.4.7

May corrosion test process affect biocompatibility of the product?

No. In our company the reagent employed is well diluted H2O2, which is usually used as whitener or disinfectant. The risk of presence of its residual on implant surface can be neglected.

35.4.8

May cleaning process after blasting affect biocompatibility of the product?

Yes. This company uses the solution with cleaning agents with anion as the main components, then cleaning with fresh water, exist detergent residue composition, thus produce biological compatibility problems

35.4.9

May product marking become a cause of implant fracture?

Yes. Improper positioning of marking, i.e. a location beyond the low-stress area or a too deep marking, may affect the mechanical property of the product

35.4.10

Is there a biocompatibility problem related to rinse following implant passivation process?

Yes. In the passivation process the reagent is diluted nitric acid. Improper rinse may result in nitric acid residual on the implant surface, which affects its biocompatibility.

35.5

Are there any mixed-up problems that may occur during the packing process of the product?

Yes. Product mix-up arising from packing mistakes during the packaging process of the product will result in the use of product with incorrect type and specification to pose hazards to the patient..

35.6

Is it possible that product is damaged in transportation and can lead to implant facture?

Yes. Implant will get scratched once the packaging is broken in transportation. Great impact will deform and damage the product, and in serious case result in fracture.

KH/JS-CE-JZ03 A/3

Risk management process The characteristics of spine products related to the safety have been identified, and the corresponding applicable questions and items

listed in Annex A, ISO 14971, have been known. The causes of these potential hazards are individually analyzed, and the risk for each hazard estimated, reevaluation of the residual risk following risk reduction measures are taken is also conducted, see the following table.

Table 2 Potential hazards of sterile spine products and risk reduction measures

Hazard which may occur Risk analysis after

risk reduction measures are taken No

Potential hazard Causes

Severity

Probabilit

y

Risk level

Risk reduction measures

applivable standards or related

documents

Is there

a new risk

severity

probability

Risk level

Acceptability level

4 35.2

Failure of implant, such as loosening and fracture

(1)Combination of dissimilar metals is made for implant, galvanic corrosion may occur after implantation, resulting in loosening for time being, and eventually fracture of the implant

2 3 6

Strengthening management of raw materials for implants, make the strictly incoming inspection of materials of implantes, after certificate, enter into the warehouse of implants ,using product circulation tracking card to follow in the production ,taking retention samples of each group of raw material in order to trace back. Advising the surgeon, in the instruction for use of product, to pay special attention not to use combination of dissimilar metals.

KH/QD-11 KH/JS-18-05 KH/JS-22.25

NO 2 1 2 ACC

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KH/JS-CE-JZ03 A/3

29

(2)The improper selection of implants and the improper fix during the insertion results the fracture of implants in the body

2 3 6

In the instruction for use ,to pay attention note

KH/JS-22.15 NO 2 1 2 ACC

35.3 3.5.4.

1

(3) Stress concentration of implant results in fracture in use

2 2 4

(1) Attention is paid to avoiding unnecessary shape edges in product design

(2) remove, by far, all micro burs on product surface in manufacture processes.(turning, milling, drilling, punching, grinding)

KH/JS-03.04.05.21 KH/JS-07ZSF/ZRF/ZJZ/ZXZ/ZRJ

NO 2 1 2 ACC

35.4.9

(4) Incorrect location and depth of marking deteriorate mechanical performance of implant and may lead to breakage in use.

2 2 4

The low stress areas of a product have been indicated in drawings and depth of marking has been specified, they have been validated.

KH/JS-04.1 KH/JS-09.09 NO 2 1 2 ACC

Continued Table 2 Potential hazards of sterile spine products and risk reduction measures

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KH/JS-CE-JZ03 A/3

Hazard which may occur Risk analysis after risk reduction measures are

taken No Potentialhazard Causes

Severity Probability Risklevel



documents Potential hazard

Is there a

new risk

Causes

Severity Probability Risk level

Acceptability

level

21

Failure of implant, such as loosening and fracture

(5) Fatigue break of implant may be caused by prolonged usage of implant in the patient’s body because of the patient’s physical status.

2 4 8

Contraindications are defined in the product instructions for use.

KH/JS-22.15 NO 2 4 2 ACC

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KH/JS-CE-JZ03 A/3

22

(6) The product may deform or break in the patient’s body because of excessive body weight or motion of the patient.

2 4 8

Surgeons are required in the instructions for use to warn the patient about postoperative cautions

KH/JS-22. 15 NO 2 4 2 ACC

29

(7) Fatigue break of implant may be caused by prolonged usage of implant in the patient’s body because of the patient’s physical status.

2 2 4

Contraindications are defined in the product instructions for use..

KH/JS-22. 15 NO 2 4 2 ACC

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26

(8) Implant is installed for patient by (orthopaedic) surgeon incompetent of necessary skills.。

2 2 4

It is specified in the instructions for use that the product is only sold to licensed (orthopaedic) surgeons.

KH/JS-22. 15 NO 2 4 2 ACC

35.4.2

(9) Galvanic corrosion in the body caused by micro-burs produced in polishing process eventually lead to implant breakage.

2 2 4

Relevant work instructions were issued and strictly implemented. In addition, micro-burs are removed in electric polishing process...

KH/JS-09.06KH/JS-09.12 NO 2 4 2 ACC

24 (10)The implants are reused.

2 2 4

Never reuse is warned in the instructions for use

KH/JS-22.15 NO 2 4 2 ACC

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KH/JS-CE-JZ03 A/3

Continued Table 2 Potential hazards of sterile spine products and risk reduction measures

Hazard which may occur Risk analysis after risk reduction measures are

taken

No Potentialhazard Causes

Severity

Probability

Risk

level



documents Potential hazard

Potential hazard

Is there a

new risk

CausesCauses

Severity

Probability

Risk

level

Acceptability

level

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KH/JS-CE-JZ03 A/3

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Residual in the production process dusts remain on the surface may pose hazards to the patient

(1) Residual blasting dusts remain on the surface may pose hazards to the patient

2 5 10

Qualified and validated each cleaning process ,make the work instruction of cleaning process ,and then send the products to institute of radiation of Suzhou university to make biology and evaluation test ,validate the rationality of the production process, train the cleaning operators , the cleaning operators strictly follow the requirements of work instruction ,and make the cleaning records ,ensure each cleaning process follow the requirements . If the composition of cleaning agents or cleaning methods change, re-qualified and re-validated

KH/JS-09.20～25 KH/JS-09.13 SRPSU-2004-0649 SRPSU-2004-0650 SRPSU-2004-0651 SRPSU-2004-0652 SRPSU-2004-0653 SRPSU-2004-0654 SRPSU-2004-0655

NO 2 2 4 ACC

KH/JS-CE-JZ03 A/3

(2) Residual polishing dusts remain on the surface may pose hazards to the patient

2 5 10

NO 2 2 4 ACC

35.4.1

(3) Residual passivation dusts remain on the surface may pose hazards to the patient

2 5 10 NO 2 2 4 ACC

35.6

(4) Residual dusts remain on the surface may pose hazards to the patient

2 5 10 NO 2 2 4 ACC

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KH/JS-CE-JZ03 A/3

35.4.8

(5) Residual blasting dusts remain on the surface may pose hazards to the patient

2 2 4 NO 2 4 2 ACC

35.4.3

(6) Acid solution residual on the surface cleaning after polishing may pose hazards to the patient

2 5 10 NO 2 2 4 ACC

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The deviation of size in the processing cause the difficulties of implant surgery

In the product machining process can produce the connecting problem with the instruments auxiliary in the corresponding operation, then affect the insertion of spine implant in the fixation and take out surgery of patients

2 4 8

Adopting high precision machining center to manufacture the key procedure sizes. In processing ,control strictly ,strengthen the processing inspection .

NO 2 4 2 ACC

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KH/JS-CE-JZ03 A/3

35.7

In the packaging process produce the mixed production

The mixed production produce the inapplicability of surgery

3 3 9

In the packaging process, print the label with bar code according to the batch number of the same products.

NO 3 1 3 ACC

35.6

In the transportation affect the product

In the transportation ,the products are affected by outing shock, happened the deformation of products and scratch on the surface of products

2 5 10

Design the package of product into box package which can be against outing force

NO 2 1 2 ACC

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KH/JS-CE-JZ03 A/3

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35.8

(1)Before using ,the operators do not make sterilization according to rules

2 3 6

In the work instruction of products, inform that the products are not sterilization and the sterilization method with steam

KH/JS-22.15

NO 2 1 2 ACC

35.9

After surgery , infection for patient

(2)In the surgery do not strictly follow the requirements of sterilization

2 2 4

In the operation strictly follow the instruction of sterilization ,can reduce the infection after operation

KH/JS-22.15

NO 2 1 2 ACC

KH/JS-CE-JZ03 A/3

a7.1 7.1 Acceptance Criteria The company divide the severity into five levels, details in table 3

Table 3 Severity assessment scale

severity lever S Serious situation Assessment level

No any danger S1 Negligible 0

Mild S2 may result injury or not 1

Serious S3 result injury 2

Fatal S4 could result one patient’s death or serious injury

3

Catastrophe S5 could result patients’ death 4

The definition of serious injury： a、Life is threatened b、Permanent damage of body function or the instruction of human body； c、The injury / damage require medical or surgical repair. 7.2 Assessment criterion of frequency Our company divide the quantitative analysis of orthopedic medical devices into six levels, see details of table 4

Table 4 Definition of Probability

Probability of occurrence P Frequency ( times/yr) Expression approach

Rare P1 ＜10-6 1 Very Little P2 10-4~10-6 2 Little P3 10-2~10-4 3 Occasional P4 10-1~10-2 4 Sometimes P5 1~10-1 5 Often P6 ＞1 6

7.3 Assessment of risk level Orthopedic implants risk assessment based on the following formula ： risk level= Frequency×severity The overall risk level described in Table 5

Table 5 Comprehensive description table of risk level severity

S2 S3 S4 S5 Frequency No any danger Serious Fatal Catastrophe

P6 Often ALARP NAC NAC NAC P5 Sometimes ALARP ALARP NAC NAC P4 Occasional ALARP ALARP ALARP NAC P3 Little ACC ALARP ALARP ALARP

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KH/JS-CE-JZ03 A/3

P2 Very Little ACC ACC ALARP ALARP P1 Rare ACC ACC ACC ACC

注：ACC is acceptable，ALARP is reasonable and feasible region，NAC is unacceptable

7.4 Acceptable risk criteria

The orthopedic implants products of our company, integrated by the level of risk, its

evaluation of the acceptance criteria is seen in Table 6

Table 6 Risk Assessment Table

Ⅰ （1-5） The risk may be negligible

Ⅱ (6-11) Allowable risk (has taken reasonable and practicable reduction measures)

Ⅲ (12-17) No hopeful, conditional permit risk (further reduce is unrealistic)

Ⅳ (18-24) No allowed risk

8 Post-production information

Department Factual description Corrective measures Verification

measures

Warranty

Department

According to the monthly "yield and reject rate tables" and the annual "Product Quality Analysis and Trends report", the completion of the quality target of the yield, the rate of waste materials, industrial waste processing rate of the products are better than the set target

-- --

marketing service

Technical service

personnel are not

sufficient; certificate

number is not enough to

place; the number of

certificate is not enough.

occasional delivery is not

timely。

1、Strength en the training

of technical service

staff, improve service

quality；

2、Increase the number of

certification of single

package.

3、Under reasonable

circumstances, the

timely delivery

according to customer

KH/JS-18.1

KH/JS-04.4

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requirements。

9 Overview The spine implant products of our company , taking analysis according to ISO14971 requirements ,totally found 4 cases that cause harm ,after taking the appropriate measures ,the risk has been reduced to an acceptable range..

Currently, our company take the strictly monitor for each manufacture process of the

products, control the whole quality ,ensure the quality of the product, meet MDD93/42/EEC

(amanded by 2007) regulations. All about the danger risk of the spine implant products were

described and evaluated ,the risk are in acceptable range. The feedback information after

production prove that under normal circumstances , it would not cause harm to the operator

and patient, also not cause life danger , therefore ,we believe that the risk of spine implant

products, compared with its benefits, benefits and more than risk.

10 Related / supporting documents

MDD 93/42/EEC（amanded by 2007）

ISO 14971 Medical Device Risk Management for Medical Device Applications

KH/QP-CE03 Medical Product Risk Management Program

Department Staff Date

产品风险管理报告 KH/JS-CE-WJJZ03 B/2

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产品风险管理报告 KH/JS-CE-WJJZ03 B/2

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product risk management report for spine products

Documents

medical devices iso

standard practice

system astm

spine products

stainless steel astm

group of risk analysis

standard guide

standard specification