FDA Adverse Event
Injury
Summary report: N
INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE
MDR report key: 6099793
·
Received November 14, 2016
Report
- Report Number
- 3007617183-2016-00003
- Event Type
- Injury
- Date Received
- November 14, 2016
- Date of Event
- April 6, 2016
- Report Date
- November 11, 2016
- Manufacturer
- VERTEBRAL TECHNOLOGIES INC.
- Product Code
- MAX
- UDI-DI
- 00819475010113
- PMA / PMN Number
- K093675
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A SECOND DEVICE, THAT HAD BEEN IMPLANTED IN L5-S1, WAS LEFT AS IT WAS, AS IT PRESENTED NORMAL.
Description of Event or Problem · 1
THE SURGEON, THROUGH THE DISTRIBUTOR, REPORTED THE C MODULE DISENGAGED AT L4-L5. REOPERATION WAS CONDUCTED TO REMOVE THE C MODULE. THE REMAINING MODULES WERE LEFT IN THE DISC SPACE, AS BONY STRUCTURES WERE APPARENT IN THE A AND B MODULES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 750081 | INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE | INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE | MAX | VERTEBRAL TECHNOLOGIES INC. | 9076-12-20-5 | 150316-01 | 00819475010113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention | FACET SCREWS |