Complaint
| Product Name | Thoracic Infralaminar Hook Orthopedic Plates and Screws |
| Material | The CanTSP are made of Titanium alloy. |
| Color | Customized |
| Standard | ISO 13485,ISO9001,QSR820,CE |
| Indication | The device provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1)trauma (i.e. fracture or dislocation), (2)curvatures (scoliosis, kyphosis, and/or lordosis), (3)spinal tumor, (4)failed previous fusion, (5)pseudarthrosis, (6)spinal stenosis. It is not intended for pedicle screw fixation above T8. |
| Contraindications | 1.Severe osteoporosis sufferer; 2.Sensitive sufferer on implant material known or under suspicion; 3.Sufferer under behaviour un-controlled; 4.Sufferer with metabolism and immunology dysfunction; 5.Spinal cord or nerve damnification; 6.Other sufferers not suitable for spinal inner operation according to clinical determination. |
| PRECAUTIONS: | 1.The spinal fixation system has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of spinal fixation system in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. 2.Inner implant shall be taken out in time after expiry or cure according to clinical examination. 3.The inner implant can not replace normal bone, the patient shall be told to conduct suitable recovery excises, but over load and acute movement is forbidden. 4.Do not use the inner implant with different materials or from different manufacturers together. 5.Rod of spinal fixation system can be transfigured if necessary, to obtain the shape similar with spinal column, but particular tools are necessary, and bending come-and-go is forbidden, otherwise will potentially cause breaking and invalid. 6.The operation doctor shall have abundant clinical experience, and familiar with inner fixation operation, inner implant and accessory devices. |
| Description | Qty. |
| Rod Holder | 1 |
| Power Grip,Length 293mm | 2 |
| Rod Template Length 210mm | 1 |
| Thoracic Speed Shift | 1 |
| Lumbar Speed Shift | 1 |
| Awl | 1 |
| Quick Coupling T-handle | 1 |
| Quick Coupling Handle | 2 |
| Dual Sides Probe | 1 |
| Probe | 1 |
| Rod Bender | 1 |
| Awl with Palm Handle | 1 |
| Torque Limiter( 12N.M) | 1 |
| Crosslink Set Driver(SW3.5) | 1 |
| Rod Template(500mm) | 1 |
| Marker Inserter(Left) | 3 |
| Marker Inserter(Right) | 3 |
| C-shaped Rod Pusher | 1 |
| Rod Pusher(6.0mm) | 1 |
| Awl with Palm Handle | 1 |
| Dual End Rod Rotation Wrench | 1 |
| Crosslink Holder | 1 |
| Countertorque, for crosslink | 1 |
| SW5.5 Crosslink Nut Driver | 1 |
| SW8 Crosslink Nut Driver | 1 |
| Parallel Distraction Forceps | 1 |
| Parallel Compression Forceps | 1 |
| Instruments Tray(Universal) | 1 |
| Description | Qty. |
| Tap(4.5mm) | 1 |
| Tap(5.0mm) | 1 |
| Tap(5.5mm) | 1 |
| Tap(6.0mm) | 1 |
| Tap(6.5mm) | 1 |
| Rod Bender, left | 1 |
| Rod Bender, right | 1 |
| In-situ Bender, left | 1 |
| In-situ Bender, right | 1 |
| Self-retaining Break-off Driver | 1 |
| Stardrive screwdriver | 1 |
| Quick Coupling Plug driver | 2 |
| Reduction Screw Tab Breaker | 1 |
| Dual End Plug Starter(short) | 2 |
| Universal Spinal Screw Tray | 1 |
| Monoaxial Screwdriver | 1 |
| Reduction Monoaxial Screwdriver | 1 |
| Polyaxial Screwdriver | 1 |
| Reduction Polyaxial Screwdrive | 1 |
| Reduction Forceps | 1 |
| Extender | 1 |
| Lateral Translator | 1 |
| Plug Starter | 1 |
| Counter Torque Wrench | 1 |
| Instruments tray(TSP5.5) | 1 |
| Description | Qty. |
| Wide blade Lamina Elevator | 1 |
| Narrow blade Lamina Elevator | 1 |
| Pedicle Elevator | 1 |
| Transverse Process Elevator | 1 |
| Hook Pusher for Implant Holder | 1 |
| Implant Pusher for Dual Purpose Instrument | 1 |
| Lateral Implant Holder | 2 |
| Dual Purpose Instrument | 1 |
| Universal Spinal Screw Tray | 1 |
| Instruments tray(TSP5.5 Correction) | 1 |
