FDA Adverse Event
Injury
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 2440344
·
Received February 1, 2012
Report
- Report Number
- 3004485144-2012-00007
- Event Type
- Injury
- Date Received
- February 1, 2012
- Date of Event
- January 11, 2012
- Report Date
- January 19, 2012
- Manufacturer
- LANX, INC
- Product Code
- MNI
- PMA / PMN Number
- 043484
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ASSOCIATED INSTRUCTIONS FOR USE LISTS SECOND SURGERY AND DURAL TEARS AS POSSIBLE COMPLICATIONS.
Description of Event or Problem · 1
THE PT UNDERWENT REVISION SURGERY TO TREAT A CEREBROSPINAL FLUID LEAK THAT DEVELOPED SUBSEQUENT TO IMPLANTATION OF A LUMBAR PEDICLE SCREW CONSTRUCT. THERE WAS NO REPORT OF A PRODUCT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANX SPINAL FIXATION SYSTEM | SPINAL FIXATION SYSTEM | MNI | LANX, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Required Intervention |