FDA Adverse Event
Injury
Summary report: N
INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE
MDR report key: 4023510
·
Received August 13, 2014
Report
- Report Number
- 3007617183-2014-00003
- Event Type
- Injury
- Date Received
- August 13, 2014
- Date of Event
- July 29, 2014
- Report Date
- August 13, 2014
- Manufacturer
- VERTEBRAL TECHNOLOGIES INC.
- Product Code
- MAX
- PMA / PMN Number
- K110226
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DR. (B)(6) PERFORMED MEDICAL INTERVENTION FOR THIS (B)(6) ON (B)(6) 2014. THE INTERFUSE T DEVICE WAS REMOVED ENTIRELY AND WAS REPLACED WITH INTERVERTEBRAL BODY FUSION DEVICE FROM ANOTHER MANUFACTURER.
Description of Event or Problem · 1
THIS IS THE 2ND ADVERSE EVENT REPORT FOR THE SAME PATIENT. THE FIRST (B)(6) WAS REPORTED PER 3007617183-2014-00001. A FEW WEEKS AFTER THE INITIAL REVISION SURGERY, THE PATIENT REPORTED ADDITIONAL PAIN. IMAGING SHOWED THAT THE B AND C MODULES HAD AGAIN MIGRATED. ANOTHER SURGERY WAS PERFORMED ON (B)(6) 2014 TO REMOVE THE INTERFUSE T IMPLANT ENTIRELY. A NEW INTERVERTEBRAL BODY FUSION DEVICE FROM ANOTHER COMPANY WAS IMPLANTED AND THE PATIENT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 483158 | INTERFUSE T INTERVERTEBRAL BODY FUSION DEVICE | MAX | VERTEBRAL TECHNOLOGIES INC. | 9091-10-20-10-Q | 131014-15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |