FDA Adverse Event
Injury
Summary report: N
AXIALF SYSTEM
MDR report key: 1044620
·
Received May 12, 2008
Report
- Report Number
- 3004578806-2008-00009
- Event Type
- Injury
- Date Received
- May 12, 2008
- Date of Event
- April 7, 2008
- Report Date
- April 22, 2008
- Manufacturer
- TRANS1 INCORPORATED
- Product Code
- JDN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MFR HAS RECEIVED NO REPORT FROM THE USER FACILITY AND IS NOT AWARE OF WHETHER OR NOT THE USER FACILITY IS REPORTING THIS EVENT. THE TRAINING, MANUFACTURING PROCESS, DESIGN, INSPECTION, TESTING, LOT RECORDS, ETC WERE EVALUATED.
Description of Event or Problem · 1
BOWEL INJURY TREATED WITH TEMPORARY COLOSTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIALF SYSTEM | ANTERIOR SPINAL FIXATION | JDN | TRANS1 INCORPORATED | 043116207H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |