FDA Adverse Event
Other
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 3216979
·
Received July 5, 2013
Report
- Report Number
- 3004485144-2013-00020
- Event Type
- Other
- Date Received
- July 5, 2013
- Date of Event
- June 17, 2013
- Report Date
- June 17, 2013
- Manufacturer
- LANX, INC.
- Product Code
- MNI
- PMA / PMN Number
- 120399
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE IFU WAS REVIEWED (IFU7721-0112.01) AND FOUND TO SUFFICIENTLY PROVIDE INSTRUCTIONS ON MAINTAINING CONTROL OF THE GUIDE WIRE DURING THE PROCEDURE.
Description of Event or Problem · 1
A GUIDE WIRE WAS PREMATURELY REMOVED DURING A SURGERY WHICH LED TO A 30 MINUTE SURGICAL EXTENSION WHILE THE GUIDE WIRE WAS REPLACED TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308012 | LANX SPINAL FIXATION SYSTEM | PEDICLE SCREW SPINAL SYSTEM | MNI | LANX, INC. | 7706-1010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | (B)(4) |