Metal bone plate quality appraisal

Metal bone plates usually consist of one or more metal components (such as plates, nail plates, blade plates) and metal fastening devices (such as screws, nails, bolts, nuts, washers). Generally made of pure titanium and titanium alloys, stainless steel, cobalt chromium molybdenum and other materials. The metal parts are held in place by fastening devices. It is mainly used for the treatment of upper limb fractures, such as the repair of fractures of the humerus, radius, ulna, etc. This system holds the fracture ends together with metal locking plates and applies appropriate pressure to promote healing and reconstruction of the fracture fragments. During the operation, the surgeon will select an appropriate bone plate system for surgical treatment based on the patient's specific conditions.
In the case of metal bone plate quality appraisal, Zhongke Testing can provide metal bone plate quality appraisal services.

YY 0017-2016 Bone joint implants Metal bone plates
YY/T 1655-2019 Bone joint implants Fretting corrosion test methods for bone plates and bone screws
YY/T 0342-2020 Surgical implants Determination of bending strength and stiffness of bone plates
YY/T 1506-2016 Surgical implants - Test method for rotation torque of metal bone screws
YY/T 1505-2016 Surgical implants - Test method for self-tapping performance of metal bone screws
YY/T 1504-2016 Surgical implants - Test method for axial pullout force of metal bone screws
YY/T 1503-2016 Surgical implants - Test method for fatigue performance of metal bone plates
YY 0018-2016 Bone joint implants - Metal bone screws
YY/T 0662-2008 Surgical implants - Metal bone screws with asymmetric threads and spherical lower surfaces Mechanical performance requirements and test methods

1. Cause: According to the information provided by the client, the demander was hospitalized at the supplier's office for a fractured calf, and the "metal bone plate" involved in the case was surgically implanted. Later, during the follow-up visit, the demander found that the "metal bone plate" involved in the case was broken in the body. The demander believed that the "metal bone plate" involved in the case had quality defects that caused the fracture. In order to clarify the cause of the fracture of the "metal bone plate" involved in the case and whether there were quality problems, the supplier proposed to conduct quality appraisal.
2. Process: The client sent the "metal bone plate" involved in the case to our company, and our company observed and inspected its appearance.
3. Result: The identification expert group discussed and comprehensively analyzed the relevant information, on-site investigation and test data of the "metal bone plate" involved in the case, and gave the following identification opinions:
(1) The cause of the fracture of the "metal bone plate" involved in the case was fatigue fracture;
(2) The hardness of the tibial metal bone plate did not meet the requirements of YY 0017-2016 "Bone Joint Implants" "Metal Bone Plate" requirements;
(3) Under the current conditions, no direct cause of the fatigue fracture of the "metal bone plate" involved in the case has been found.