FDA Adverse Event
Injury
Summary report: N
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
MDR report key: 2973839
·
Received February 18, 2013
Report
- Report Number
- MW5029022
- Event Type
- Injury
- Date Received
- February 18, 2013
- Date of Event
- March 16, 2009
- Report Date
- December 3, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NEK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
MY SURGEON USED THE MEDTRONIC INFUSE WHICH CAUSED ME SIGNIFICANT PAIN, MAJOR RESPIRATORY PROBLEMS AND MENTAL ANGUISH RENDERING MENTALLY AND PERMANENTLY DISABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 70973 | MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 | MEDTRONIC INFUSE | NEK | MEDTRONIC, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |