FDA Adverse Event
Other
Summary report: N
AXIALIF 2-LEVEL SYSTEM
MDR report key: 1198948
·
Received October 8, 2008
Report
- Report Number
- 3004578806-2008-00024
- Event Type
- Other
- Date Received
- October 8, 2008
- Date of Event
- January 11, 2008
- Report Date
- July 31, 2008
- Manufacturer
- TRANS1 INCORPORATED
- Product Code
- JDN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
"OTHER MEANING THAT THE TRAINING, INSPECTION, LOT RECORDS, ETC. WERE EVALUATED.
Description of Event or Problem · 1
TWO INSTANCES IN A SINGLE SURGERY OF INTRA-OPERATIVE BLOOD PRESSURE DROP THAT WERE SUCCESSFULLY MITIGATED THROUGH INTERVENTION TO RESTORE NORMAL BP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIALIF 2-LEVEL SYSTEM | ANTERIOR SPINAL FIXATION | JDN | TRANS1 INCORPORATED | 043604908B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |