Definition: This Device Is An Interspinous Spacer Or Spinous Process Plate That Is Implanted Between The Spinous Processes Or Attached To The Spinous Process.
| Device Type ID | 4738 |
| Device Name | Prosthesis, Spinous Process Spacer/plate |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NQO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4738 |
| Device | Prosthesis, Spinous Process Spacer/plate |
| Product Code | NQO |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 46 |
Insufficient Information | 14 |
Migration Or Expulsion Of Device | 12 |
Improper Or Incorrect Procedure Or Method | 6 |
Break | 4 |
Fracture | 3 |
Difficult Or Delayed Positioning | 3 |
Device Dislodged Or Dislocated | 3 |
Use Of Device Problem | 2 |
Activation, Positioning Or Separation Problem | 2 |
Patient-Device Incompatibility | 2 |
Material Fragmentation | 2 |
Device Handling Problem | 1 |
No Pressure | 1 |
Unintended Movement | 1 |
Malposition Of Device | 1 |
Material Integrity Problem | 1 |
Osseointegration Problem | 1 |
Difficult To Open Or Close | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 108 |