FDA Adverse Event
Injury
Summary report: N
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
MDR report key: 2915710
·
Received January 9, 2013
Report
- Report Number
- MW5028512
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- March 23, 2010
- Report Date
- December 10, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NEK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
MY SURGEON USED THE MEDTRONIC INFUSE DURING MY SURGERY. THIS CAUSED ME SIGNIFICANT PAIN, NERVE INJURIES, AND MENTAL ANGUISH. I'M CONSTANTLY WORRIED THINGS WILL GET WORSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12561 | MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 | MEDTRONIC INFUSE | NEK | MEDTRONIC, INC. | UNK | UNK | |
| 12562 | MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 | MEDTRONIC INFUSE | NEK | MEDTRONIC, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| R| S |