FDA Adverse Event
Injury
Summary report: N
INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE
MDR report key: 3117836
·
Received May 13, 2013
Report
- Report Number
- 3007617183-2013-00002
- Event Type
- Injury
- Date Received
- May 13, 2013
- Date of Event
- April 12, 2013
- Report Date
- May 13, 2013
- 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 EXPLANT MODULE #3 (B) AND MODULE #4 (C). THE REMAINING TWO MODULES (A AND B) WERE LEFT IN THE DISC SPACE. THE PATIENT IS DOING WELL.
Description of Event or Problem · 1
FOUR (4) MODULE INTERFUSE S WAS IMPLANTED ON (B)(6) 2013. MODULE #2 DISCONNECTED FROM MODULE #3. THE SURGEON REVISED THE SURGERY AND REMOVED MODULE #3 (B) AND MODULE #4 (C). THE TWO MODULES (A AND B) WERE LEFT IN THE DISC SPACE. THE PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210583 | INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE | INTERVERTEBRAL BODY FUSION DEVCIE | MAX | VERTEBRAL TECHNOLOGIES INC. | 9076-10-20-5 | 120823-07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |