FDA Adverse Event
Injury
Summary report: N
INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE
MDR report key: 2919753
·
Received January 11, 2013
Report
- Report Number
- 3007617183-2013-00001
- Event Type
- Injury
- Date Received
- January 11, 2013
- Date of Event
- December 19, 2012
- Report Date
- January 11, 2013
- Manufacturer
- VERTEBRAL TECHNOLOGIES INC.
- Product Code
- MAX
- PMA / PMN Number
- K110226
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DR. (B)(6) DECIDED TO TAKE OUT THE ENTIRE DEVICE AND REPLACE WITH A DEVICE FROM ANOTHER MANUFACTURER.
Description of Event or Problem · 1
THE "C" MODULE OF THE DEVICE HAD MIGRATED RESULTING IN PAIN. THE ENTIRE DEVICE WAS SUCCESSFULLY REMOVED IN A SURGERY ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18487 | INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE | INTERVERTEBRAL BODY FUSION DEVICE | MAX | VERTEBRAL TECHNOLOGIES INC. | 9091-10-20-0-Q | 120927-06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |