FDA Adverse Event
Injury
Summary report: N
INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE
MDR report key: 6558966
·
Received May 10, 2017
Report
- Report Number
- 3007617183-2017-00001
- Event Type
- Injury
- Date Received
- May 10, 2017
- Date of Event
- April 11, 2017
- Report Date
- May 10, 2017
- Manufacturer
- VERTEBRAL TECHNOLOGIES INC.
- Product Code
- MAX
- UDI-DI
- 00819475010113
- PMA / PMN Number
- K093675
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT PRESENTED AT APPROXIMATELY ONE MONTH POST-OP WITH PAIN. IMAGING REVEALED FUSION CONSTRUCT FAILURE, BOTH SCREWS (SCREWS NOT PROVIDED BY VTI) AND INTERBODY. THE DOCTOR STATED THE PATIENT WAS HIGH RISK (HIGH BMI AND OSTEOPENIC BONE). SCREWS AND INTERBODY WERE REVISED. A REVIEW OF THE IMAGES SHOWED THE SECOND B MODULE IS NO LONGER LOCKED TO THE FIRST B MODULE AND HAS MIGRATED, WITH ATTACHED C MODULE, ABOUT 10MM POSTERIORLY. IN ADDITION, THE DEVICE IS ROTATED SLIGHTLY IN THE DISC SPACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340497 | INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE | INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE | MAX | VERTEBRAL TECHNOLOGIES INC. | 9076-12-20-5 | 120705-05 | 00819475010113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention | SCREWS |