FDA Adverse Event
Injury
Summary report: N
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
MDR report key: 2915741
·
Received January 10, 2013
Report
- Report Number
- MW5028526
- Event Type
- Injury
- Date Received
- January 10, 2013
- Date of Event
- September 5, 2008
- Report Date
- December 26, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NEK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD THE INFUSE IMPLANTED DURING MY SPINAL SURGERY. THIS HAS CAUSED ME MANY SERIOUS PROBLEMS INCLUDING PAIN, A DIAGNOSIS OF CANCER, AS WELL AS, PHYSICAL LIMITATIONS. I'M WORRIED I WILL NEVER BE WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13184 | MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 | MEDTRONIC INFUSE | NEK | MEDTRONIC, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| L| R |