FDA Adverse Event
Injury
Summary report: N
AXIALIF 2L
MDR report key: 1374317
·
Received May 4, 2009
Report
- Report Number
- 3004578806-2009-00014
- Event Type
- Injury
- Date Received
- May 4, 2009
- Date of Event
- April 14, 2009
- Report Date
- April 14, 2009
- Manufacturer
- TRANS1 INCORPORATED
- Product Code
- JDN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER DOES NOT KNOW WHETHER OR NOT THE USER FACILITY IS REPORTING THIS EVENT. THERE WAS NO EVIDENCE OF OUT OF SPECIFICATION CONDITION THAT COULD HAVE CONTRIBUTED TO THIS EVENT. IN RETROSPECT, DURING TREATMENT OF THE INJURY, IT WAS LEARNED THAT BOWEL WALL WAS VERY THIN AND THAT THE PATIENT HAD A HISTORY OF HEAVY ALCOHOL USAGE. THE CONDITION OF THE BOWEL WAS NOT KNOWN BEFORE THE SURGERY, BUT IT APPEARS VERY LIKELY TO BE A FACTOR IN THIS EVENT.
Description of Event or Problem · 1
BOWEL INJURY TREATED WITH TEMPORARY DIVERTING COLOSTOMY AND GRAM NEGATIVE ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIALIF 2L | ANTERIOR SPINAL FIXATION | JDN | TRANS1 INCORPORATED | 043620708G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| R |