FDA Adverse Event
Other
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 2960658
·
Received February 12, 2013
Report
- Report Number
- 3004485144-2013-00004
- Event Type
- Other
- Date Received
- February 12, 2013
- Date of Event
- November 30, 2012
- Report Date
- December 3, 2012
- Manufacturer
- LANX, INC.
- Product Code
- MNI
- PMA / PMN Number
- 071877
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD: NO TESTING METHODS PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MANUFACTURER). RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MANUFACTURER). CONCLUSIONS: REUSE OF SINGLE USE DEVICE. DEVICE NOT RETURNED.
Description of Event or Problem · 1
A LANX INTERSPINOUS PROCESS DEVICE THAT WAS PREVIOUSLY USED IN AN EDUCATIONAL SETTING WAS USED IN SURGERY. TO DATE THERE HAVE BEEN NO REPORTS OF ANY ADVERSE EVENTS RELATED TO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61153 | LANX SPINAL FIXATION SYSTEM | INTERSPINOUS PROCESS SPINAL SYSTEM | MNI | LANX, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |