FDA Adverse Event
Injury
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 2051056
·
Received April 5, 2011
Report
- Report Number
- 3004485144-2011-00025
- Event Type
- Injury
- Date Received
- April 5, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 6, 2011
- Manufacturer
- LANX, INC.
- Product Code
- KWP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED SO NO FURTHER EVALUATION COULD BE PERFORMED.
Description of Event or Problem · 1
THE PATIENT UNDERWENT A REVISION SURGERY AT L5-S1. AN INTERSPINOUS FIXATION DEVICE WAS REMOVED FROM THE PATIENT TO ALLOW THE SURGEON TO REVISIT THE SITE TO FURTHER DECOMPRESS. THE SURGEON REPLACED THE DEVICE WITH A LARGER IMPLANT TO PROVIDE FURTHER DECOMPRESSION OF THE PATIENT'S FORAMINA AND DISCECTOMY. COMMENTARY FROM THE REPORTER STATED THAT THE HARDWARE DID NOT FAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANX SPINAL FIXATION SYSTEM | SPINOUS PROCESS FUSION PLATE | KWP | LANX, INC. | 6211-0010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | ALLOFUSE DBM |