| Device Type ID | 4722 |
| Device Name | Prosthesis, Intervertebral Disc |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Anterior Spine Devices Branch (ASDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MJO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4722 |
| Device | Prosthesis, Intervertebral Disc |
| Product Code | MJO |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 312 |
Migration Or Expulsion Of Device | 183 |
Appropriate Term/Code Not Available | 32 |
Unintended Movement | 32 |
Break | 23 |
Insufficient Information | 20 |
Malposition Of Device | 16 |
Patient-Device Incompatibility | 15 |
Migration | 15 |
Mechanical Problem | 14 |
Device Slipped | 13 |
Device Dislodged Or Dislocated | 13 |
Positioning Problem | 10 |
Detachment Of Device Or Device Component | 9 |
Device Operates Differently Than Expected | 9 |
Failure To Adhere Or Bond | 7 |
Use Of Device Problem | 7 |
Device Inoperable | 6 |
Fitting Problem | 6 |
Device Handling Problem | 6 |
Patient Device Interaction Problem | 5 |
Positioning Failure | 5 |
Material Separation | 4 |
Expulsion | 4 |
Loose Or Intermittent Connection | 4 |
Device Operational Issue | 4 |
Metal Shedding Debris | 4 |
Disassembly | 4 |
Misassembled | 4 |
Fracture | 3 |
Difficult To Insert | 3 |
Collapse | 3 |
Plate | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Sticking | 2 |
Device-Device Incompatibility | 2 |
Material Deformation | 2 |
Sensing Intermittently | 2 |
Spacer | 2 |
Sensor | 2 |
Failure To Sense | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Component Missing | 2 |
Failure To Cut | 1 |
No Apparent Adverse Event | 1 |
Material Split, Cut Or Torn | 1 |
Electromagnetic Compatibility Problem | 1 |
Device Sensing Problem | 1 |
Unstable | 1 |
Material Disintegration | 1 |
Component Falling | 1 |
Material Erosion | 1 |
Noise, Audible | 1 |
Naturally Worn | 1 |
Packaging Problem | 1 |
Torn Material | 1 |
Crack | 1 |
Device Expiration Issue | 1 |
Defective Device | 1 |
Blocked Connection | 1 |
Mechanical Jam | 1 |
Misassembly By Users | 1 |
Incomplete Or Missing Packaging | 1 |
Device Issue | 1 |
Material Fragmentation | 1 |
| Total Device Problems | 841 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Sofamor Danek USA Inc | II | May-04-2018 |