FDA Adverse Event
Injury
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 2912789
·
Received January 8, 2013
Report
- Report Number
- 3004485144-2013-00001
- Event Type
- Injury
- Date Received
- January 8, 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
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD: NO TESTING METHODS PERFORMED (RELATED DEVICE WAS NOT RETURNED TO MANUFACTURER). METHOD: LABELING EVALUATION PERFORMED. THE IFU NOTES SPINOUS PROCESS FRACTURE 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
THE PATIENT EXPERIENCED A SPINOUS PROCESS FRACTURE SOME TIME AFTER A LANX INTERSPINOUS PROCESS DEVICE WAS IMPLANTED. THE SURGEON HAS SCHEDULED A REVISION SURGERY TO ADDRESS THE FRACTURED SPINOUS PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10230 | LANX SPINAL FIXATION SYSTEM | INTERSPINOUS PROCESS SPINAL SYSTEM | MNI | LANX, INC. | 6201-0012/6211-0012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |