FDA Adverse Event
Malfunction
Summary report: N
INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE
MDR report key: 4551194
·
Received February 20, 2015
Report
- Report Number
- 3007617183-2015-00001
- Event Type
- Malfunction
- Date Received
- February 20, 2015
- Date of Event
- January 1, 2009
- Report Date
- April 21, 2009
- Manufacturer
- VERTEBRAL TECHNOLOGIES INC.
- Product Code
- MAX
- PMA / PMN Number
- K091988
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EVENT WAS INITIALLY DETERMINED TO BE NOT REPORTABLE. DURING A RECENT FDA INSPECTION, IT WAS OBSERVED THAT THE EVENT SHOULD HAVE BEEN REPORTED. THAT IS THE REASON THIS REPORT IS BEING SUBMITTED NOW, INSTEAD OF WITHIN 30 DAYS OF THE INITIAL REPORT.
Description of Event or Problem · 1
DURING THE 4 MONTH FOLLOW-UP, THE X-RAY INDICATED THE C MODULE HAD MIGRATED ABOUT 3.5MM. THE DOCTOR HAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED FOR THE PATIENT, SINCE THE PATIENT HAS NOT REPORTED ANY PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124298 | INTERFUSE S INTERVERTEBRAL BODY FUSION DEVICE | INTERVERTEBRAL BODY FUSION DEVICE | MAX | VERTEBRAL TECHNOLOGIES INC. | 9076-10-20-0 | 081110-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |