MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-09 for INFUSE BONE GRAFT DEVICE (RHBMP2) manufactured by Medtronic.
[3364257]
Had tlif on l 3-4 and l4-5. Surgeon used rhbmp2, no lt cage caused abnormal bone growth, lower back pain, pain in left leg, scar tissue (pain) and numbness in leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029726 |
| MDR Report Key | 3057307 |
| Date Received | 2013-04-09 |
| Date of Report | 2013-03-22 |
| Date of Event | 2011-08-08 |
| Date Added to Maude | 2013-04-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT DEVICE (RHBMP2) |
| Generic Name | INFUSE |
| Product Code | MPW |
| Date Received | 2013-04-09 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2013-04-09 |