FDA Adverse Event
Other
Summary report: N
AXIALIF SYSTEM
MDR report key: 1246436
·
Received November 20, 2008
Report
- Report Number
- 3004578806-2008-00025
- Event Type
- Other
- Date Received
- November 20, 2008
- Date of Event
- October 22, 2008
- Report Date
- October 22, 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
THE MANUFACTURER IS NOT AWARE OF WHETHER OR NOT THE USER FACILITY IS REPORTED THIS EVENT. THIS EVENT IS BEING REPORTED, BECAUSE INTERVENTION TREATMENT (CAUTERIZATION) WAS DONE TO REPAIR A SMALL BLOOD VESSEL. THERE IS NO PERMANENT INJURY TO THE PATIENT. THE INVESTIGATION REVEALED NO EVIDENCE OF SURGICAL TECHNIQUE DEVIATION OR PRODUCT MALFUNCTION. THE CAUSE OF THE EVENT IS INCONCLUSIVE.
Description of Event or Problem · 1
PERI-RECTAL HEMATOMA. PATIENT PRESENTED WITH ABDOMINAL PAIN BUT NO FEVER. DIAGNOSTIC TESTS DETERMINED THAT THERE WAS A PRE-RECTAL HEMATOMA. THE VESSEL WAS CAUTERIZED AND THE PATIENTS SYMPTOMS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIALIF SYSTEM | ANTERIOR SPINAL FIXATION | JDN | TRANS1 INCORPORATED | 043116207C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |