FDA Adverse Event
Injury
Summary report: N
INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE
MDR report key: 2624343
·
Received June 15, 2012
Report
- Report Number
- 3007617183-2012-00001
- Event Type
- Injury
- Date Received
- June 15, 2012
- Date of Event
- February 7, 2012
- Report Date
- June 15, 2012
- Manufacturer
- VERTEBRAL TECHNOLOGIES INC.
- Product Code
- MAX
- PMA / PMN Number
- K091988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DR. (B)(6) DECIDED TO TAKE OUT ONLY THE C MODULE AND LEFT THE REMAINING 4 MODULES (ABBB) IN THE DISC SPACE AS THE REMAINING MODULES WOULD STILL PROVIDE SUFFICIENT FOOT PRINT.
Description of Event or Problem · 1
THE DEVICE WAS IMPLANTED ON (B)(6) 2012. ONE OF THE MODULES (C) BECAME LOOSE AND MOVED INTO THE CANAL. THE PT COMPLAINED ABOUT LEG PAIN. ON (B)(6) 2012, THE SURGEON INTERVENED AND TOOK OUT THE C MODULE AND LEFT THE REMAINING 4 MODULES IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE | INTERVERTEBRAL BODY FUSION DEVICE | MAX | VERTEBRAL TECHNOLOGIES INC. | 9076-08-20-5 | 101217-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |