FDA Adverse Event
Injury
Summary report: N
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
MDR report key: 2854812
·
Received November 27, 2012
Report
- Report Number
- MW5027758
- Event Type
- Injury
- Date Received
- November 27, 2012
- Date of Event
- March 9, 2011
- Report Date
- November 1, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NEK
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I HAD THE INFUSE IMPLANTED INSIDE OF ME DURING MY SURGERY AND NOW HAVE SERIOUS PAIN AND PHYSICAL LIMITATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 | MEDTRONIC INFUSE | NEK | MEDTRONIC, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |