FDA Adverse Event
Injury
Summary report: N
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
MDR report key: 2906587
·
Received January 7, 2013
Report
- Report Number
- MW5028491
- Event Type
- Injury
- Date Received
- January 7, 2013
- Date of Event
- May 17, 2005
- Report Date
- December 17, 2012
- Manufacturer
- MEDTRONIC, INC
- Product Code
- NEK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
BECAUSE OF THE MEDTRONIC INFUSE, I BEGAN TO HAVE SERIOUS PROBLEMS - INCLUDING PAIN, MENTAL ANGUISH, PHYSICAL LIMITATIONS, AS WELL AS HAVING TO UNDER GO A REVISION SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8034 | MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 | MEDTRONIC INFUSE | NEK | MEDTRONIC, INC | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Hospitalization| R |