FDA Adverse Event
Other
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 3060470
·
Received April 11, 2013
Report
- Report Number
- 3004485144-2013-00013
- Event Type
- Other
- Date Received
- April 11, 2013
- Date of Event
- March 26, 2013
- Report Date
- April 10, 2013
- Manufacturer
- LANX, INC.
- Product Code
- KWP
- PMA / PMN Number
- 071877
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
METHOD: NO TESTING METHODS PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MANUFACTURER). LABELING EVALUATION PERFORMED. THE IFU NOTES PSEUDOARTHROSIS AS A POSSIBLE SURGICAL COMPLICATION. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MANUFACTURER). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE.
Description of Event or Problem · 1
A PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS PSEUDARTHROSIS DEVELOPED AFTER A LANX INTERSPINOUS PROCESS DEVICE WAS IMPLANTED ON (B)(6) 2012. DURING THE REVISION SURGERY, THE SURGEON REMOVED THE LANX INTERSPINOUS PROCESS DEVICE AND REPLACED IT WITH PEDICLE SCREWS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156905 | LANX SPINAL FIXATION SYSTEM | INTERSPINOUS PROCESS SPINAL SYSTEM | KWP | LANX, INC. | 6201-0012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |