MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-04 for MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 UNK manufactured by Medtronic, Inc..
[3060757]
My surgeon used the medtronic infuse during my surgery - which caused me significant pain - as well as required me to undergo a revision surgery, i'm worried things will get worse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028454 |
| MDR Report Key | 2903788 |
| Date Received | 2013-01-04 |
| Date of Report | 2012-12-20 |
| Date of Event | 2011-07-21 |
| Date Added to Maude | 2013-01-10 |
| 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 | 0 |
| 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 | MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 |
| Generic Name | MEDTRONIC INFUSE |
| Product Code | NPZ |
| Date Received | 2013-01-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| 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. Required No Informationntervention | 2013-01-04 |