FDA Adverse Event
Other
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 3294580
·
Received August 13, 2013
Report
- Report Number
- 3004485144-2013-00029
- Event Type
- Other
- Date Received
- August 13, 2013
- Date of Event
- July 16, 2013
- Report Date
- August 9, 2013
- Manufacturer
- LANX, INC.
- Product Code
- MNI
- PMA / PMN Number
- 071877
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE ASSOCIATED DHR FOUND NO DEVICE NONCONFORMITIES THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. THE PRODUCT LABELING IDENTIFIES PSEUDARTHROSIS AS POSSIBLE COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.
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 |
|---|---|---|---|---|---|---|---|
| 388432 | LANX SPINAL FIXATION SYSTEM | INTERSPINIOUS PROCESS SPINAL SYSTEM | MNI | LANX, INC. | 6201-0008-001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |