FDA Adverse Event
Other
Summary report: N
ZUMA
MDR report key: 1338653
·
Received December 22, 2008
Report
- Report Number
- 2032593-2008-00005
- Event Type
- Other
- Date Received
- December 22, 2008
- Date of Event
- December 4, 2008
- Report Date
- December 19, 2008
- Manufacturer
- SEASPINE, INC.
- Product Code
- KWQ
- PMA / PMN Number
- K072605
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. ONCE MORE INFORMATION HAS BEEN GATHERED FROM THE PHYSICIAN, SEASPINE WILL SEND IN ADDITIONAL INFORMATION.
Description of Event or Problem · 1
PATIENT MAY UNDERGO REVISION SURGERY DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZUMA | 888.3060 SPINAL INTERBODY FIXATION DEVICE | KWQ | SEASPINE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |