Definition: Intended For Injection Of Vertebroplasty Bone Cement For The Fixation Of Pathological Fractures Of The Vertebral Body Using Vertebroplasty Or Kyphoplasty Procedures. Painful Vertebral Compression Fractures May Result From Osteoporosis, Benign Lesions
| Device Type ID | 4652 |
| Device Name | Injector, Vertebroplasty (does Not Contain Cement) |
| Physical State | Plastic Syringe Type Device -- Some Embodiments May Include Levers Or Screws To Increase Injection Force Or Control |
| Technical Method | Uses Mechanical Force To Inject Bone Cement Into Vertebra |
| Target Area | Vertebra |
| Regulation Description | Cement Dispenser. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OAR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4652 |
| Device | Injector, Vertebroplasty (does Not Contain Cement) |
| Product Code | OAR |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cement Dispenser. |
| CFR Regulation Number | 888.4200 [🔎] |
| Device Problems | |
|---|---|
Break | 26 |
Device Operates Differently Than Expected | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Use Of Device Problem | 4 |
Fracture | 2 |
Material Integrity Problem | 2 |
Leak / Splash | 2 |
Detachment Of Device Component | 1 |
Material Fragmentation | 1 |
Unsealed Device Packaging | 1 |
Fluid Leak | 1 |
Torn Material | 1 |
Appropriate Term/Code Not Available | 1 |
Retraction Problem | 1 |
| Total Device Problems | 51 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Sofamor Danek USA Inc | II | Jan-14-2018 |
| 2 | Medtronic Sofamor Danek USA Inc | II | Jun-03-2017 |
| 3 | Stryker Instruments Div. Of Stryker Corporation | II | Mar-28-2018 |