MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-01 for (RHBMP-2) INFUSE BONE GRAFT DEVICE manufactured by Medtronic Inc.
[15759686]
I had a plif on (b)(6) 2007, when they used infuse off label for my ls-si surgeon. I had a bone growth which required a revision surgery on (b)(6) 2010.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030034 |
| MDR Report Key | 3095997 |
| Date Received | 2013-05-01 |
| Date of Report | 2013-03-27 |
| Date of Event | 2007-11-03 |
| Date Added to Maude | 2013-05-08 |
| 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 | (RHBMP-2) INFUSE BONE GRAFT DEVICE |
| Generic Name | INFUSE |
| Product Code | NEC |
| Date Received | 2013-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC INC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2013-05-01 |