FDA Adverse Event
Other
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 3221821
·
Received July 9, 2013
Report
- Report Number
- 3004485144-2013-00025
- Event Type
- Other
- Date Received
- July 9, 2013
- Date of Event
- June 4, 2013
- Report Date
- June 10, 2013
- Manufacturer
- LANX, INC.
- Product Code
- KWQ
- PMA / PMN Number
- 120399
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT LABELING IDENTIFIES NON-UNION OR DELAYED UNION AND SECOND SURGERY AS POSSIBLE COMPLICATIONS ASSOCIATED WITH USE OF THE DEVICE.
Description of Event or Problem · 1
REVISION SURGERY WAS PERFORMED TO ADDRESS A FAILED L4-5 FUSION UTILIZING PEDICLE SCREWS THAT WAS PERFORMED ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312434 | LANX SPINAL FIXATION SYSTEM | PEDICLE SCREW SPINAL SYSTEM | KWQ | LANX, INC. | 7716-6545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention | 7703-1600 (SET SCREW)| 7711-1040 (ROD) |