FDA Adverse Event
Injury
Summary report: N
AXIALIF 2L
MDR report key: 1413224
·
Received July 10, 2009
Report
- Report Number
- 3004578806-2009-00015
- Event Type
- Injury
- Date Received
- July 10, 2009
- Date of Event
- June 9, 2009
- Report Date
- June 9, 2009
- Manufacturer
- TRANS1 INCORPORATED
- Product Code
- JDN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER IS NOT AWARE IF THE USER FACILITY INTENDS TO REPORT THIS EVENT. NO REPORT HAS BEEN RECEIVED BY THE USER FACILITY TO DATE. THE CODE SELECTED WITH "OTHER", MEANING THAT THE TRAINING, LABELING, LOT RECORDS, AND PROVIDED INFORMATION WERE EVALUATED. THERE IS NOT EVIDENCE OF OUT OF SPECIFICATION CONDITION OF TECHNIQUE DEVIATION THAT COULD HAVE CONTRIBUTED TO THIS EVENT.
Description of Event or Problem · 1
SACRAL FRACTURE. PRESCRIBED TREATMENT IS CURRENTLY BED REST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIALIF 2L | ANTERIOR SPINAL FIXATION | JDN | TRANS1 INCORPORATED | TR1-2349 | 043629708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |