FDA Adverse Event
Injury
Summary report: N
AXIALIF SYSTEM
MDR report key: 1324340
·
Received February 23, 2009
Report
- Report Number
- 3004578806-2009-00007
- Event Type
- Injury
- Date Received
- February 23, 2009
- Date of Event
- January 26, 2009
- Report Date
- January 27, 2009
- Manufacturer
- TRANS1 INCORPORATED
- Product Code
- JDN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CODE WAS SELECTED WITH "OTHER" MEANING THAT THE TRAINING AND REPORTED DETAILS WERE EVALUATED. BASED UPON THE LIMITED AVAILABLE INFO, THERE WAS NO EVIDENCE FOUND OF AN OUT OF SPECIFICATION CONDITION THAT COULD HAVE CONTRIBUTED TO THIS EVENT. IT IS APPARENT THAT THE TRANS1 IMPLANT AND PROCEDURE WERE NOT THE SOURCE OF THE UROSEPSIS. DUE TO THE PROXIMITY OF THE INFECTION TO THE TRANS1 IMPLANT, THE SURGEON ELECTED TO REMOVE THE IMPLANT IN CONSIDERATION OF THE PT SAFETY. THUS, FOR DUE DILIGENCE, TRANS1 HAS ELECTED TO REPORT THIS EVENT.
Description of Event or Problem · 1
REVISION OF AXIALIF PROCEDURE DUE TO SYSTEMIC INFECTION. INFECTION MANAGED THROUGH ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIALIF SYSTEM | ANTERIOR SPINAL FIXATION | JDN | TRANS1 INCORPORATED | TRI-2310 | 043116207L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |