| Device Type ID | 4734 |
| Device Name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NEK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4734 |
| Device | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction |
| Product Code | NEK |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2435 |
Migration Or Expulsion Of Device | 3 |
Device Operates Differently Than Expected | 3 |
Insufficient Information | 2 |
Break | 1 |
Malposition Of Device | 1 |
Leak / Splash | 1 |
Inaudible Or Unclear Audible Prompt / Feedback | 1 |
Off-Label Use | 1 |
Patient-Device Incompatibility | 1 |
Device Dislodged Or Dislocated | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 2451 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Sofamor Danek USA Inc | II | Nov-09-2018 |