FDA Adverse Event
Injury
Summary report: N
LANX INTERVERTEBRAL BODY FUSION SYSTEM
MDR report key: 1726220
·
Received June 14, 2010
Report
- Report Number
- 3004485144-2010-00010
- Event Type
- Injury
- Date Received
- June 14, 2010
- Date of Event
- October 7, 2009
- Report Date
- May 27, 2010
- Manufacturer
- LANX, INC.
- Product Code
- MAX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
VERBAL INFORMATION SUPPLIED BY INITIAL REPORTER INDICATED THE EVENT WAS LIKELY THE RESULT OF THE PT'S CONDITION OF SEVERE SPONDYLOLISTHESIS AND SCOLIOSIS. EVALUATION OF THE DEVICE NOT PERFORMED AS NO DEVICE WAS RETURNED FOR EVALUATION.
Description of Event or Problem · 1
A PT UNDERWENT REVISION SURGERY TO REMOVE A SPINAL INTERBODY DEVICE WHICH HAD MIGRATED, CAUSING NERVE PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANX INTERVERTEBRAL BODY FUSION SYSTEM | INTERVERTEBRAL BODY FUSION DEVICE | MAX | LANX, INC. | 8841-3212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SPINAL FIXATION SYSTEM |