FDA Adverse Event
Malfunction
Summary report: N
PARAMOUNT VBR, 27MM X 10MM X 6 DEGREES
MDR report key: 1006333
·
Received February 27, 2008
Report
- Report Number
- 3005559743-2008-00003
- Event Type
- Malfunction
- Date Received
- February 27, 2008
- Date of Event
- February 19, 2008
- Report Date
- February 26, 2008
- Manufacturer
- INNOVATIVE SPINAL TECHNOLOGIES, INC. (IST)
- Product Code
- MQP
- PMA / PMN Number
- K062759
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR AND IS CURRENTLY UNDER EVAL.
Description of Event or Problem · 1
THE SURGEON IMPLANTED IST PARAMOUNT VBR AT L4-L5. BECAUSE OF THE SIZE OF THE PT AND THE STARTING ANGLE OF THE IMPLANT ON THE IST INSERTER, THE SURGEON HAD A DIFFICULT TIME ESTABLISHING THE INITIAL ENTRY ANGLE. WHEN THE VBR FIRST ENTERED THE DISC SPACE, THE SURGEON BROUGHT THE INSERTER TOWARDS HIM TO CHANGE THE ANGLE OF THE IMPLANT. AS HE BEGAN TO STEER THE IMPLANT AND RETIGHTEN IT ON THE INSERTER, THE SURGEON NOTICED THAT THE VBR HAD CRACKED. THE SURGEON REMOVED THE CRACKED VBR AND SUCCESSFULLY REPLACED IT WITH ANOTHER IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARAMOUNT VBR, 27MM X 10MM X 6 DEGREES | VERTEBRAL BODY REPLACEMENT DEVICE | MQP | INNOVATIVE SPINAL TECHNOLOGIES, INC. (IST) | 65140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 27MM X 11MM X 6 DEGREES| IST PARAMOUNT VBR |