FDA Adverse Event
Injury
Summary report: N
PARAMOUNT VBR, 27MM X 11MM X 0 DEGREES
MDR report key: 929065
·
Received October 17, 2007
Report
- Report Number
- 3005559743-2007-00003
- Event Type
- Injury
- Date Received
- October 17, 2007
- Date of Event
- September 15, 2007
- Report Date
- October 15, 2007
- Manufacturer
- INNOVATIVE SPINAL TECHNOLOGIES INC (IST)
- Product Code
- MQP
- PMA / PMN Number
- K062759
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DUE TO PREEXISTING PULMONARY DISEASE, SURGEON DECIDED NOT TO IMPLANT PEDICLE SCREW SPINAL SYSTEM AS ORIGINALLY PLANNED DURING INITIAL IN 2007 SURGERY IN ORDER TO MINIMIZE LENGTH OF SURGERY.
Description of Event or Problem · 1
IN 2007, PATIENT REC'D IST VBR AT L4-L5. PATIENT REPORTED POST-OPERATIVE PAIN. ON THE FOLLOWING MONTH, SURGEON REOPERATED ON PT AND IMPLANTED ANOTHER MFR'S PEDICLE SCREW SPINAL SYSTEM. SURGEON DID NOT EXPLANT THE IST VBR THAT WAS IMPLANTED ON ORIGINAL DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARAMOUNT VBR, 27MM X 11MM X 0 DEGREES | VERTEBRAL BODY REPLACEMENT DEVICE | MQP | INNOVATIVE SPINAL TECHNOLOGIES INC (IST) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R | OSTEOGENIC PROTEIN-1| STRYKER BIOTECH OP-1 |