FDA Adverse Event
Other
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 2757790
·
Received September 17, 2012
Report
- Report Number
- 3004485144-2012-00035
- Event Type
- Other
- Date Received
- September 17, 2012
- Date of Event
- August 16, 2012
- Report Date
- August 19, 2012
- Manufacturer
- LANX, INC.
- Product Code
- MNI
- PMA / PMN Number
- 043484
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
THE ASSOCIATED INSTRUCTIONS FOR USE LISTS EARLY OR LATE IMPLANT BENDING, BREAKAGE, OR FAILURE AS POSSIBLE COMPLICATIONS.
Description of Event or Problem · 1
THE PT UNDERWENT A REVISION SURGERY TO ADDRESS NON-UNION AND REMOVE TWO BROKEN PEDICLE SCREWS. THE CONSTRUCT WAS ORIGINALLY IMPLANTED ON (B)(6) 2011 AND WAS REPLACED WITH ALL NEW HARDWARE DURING THE REVISION. PT FACTORS, INCLUDING SMOKING, OBESITY, AND NON-COMPLIANCE WITH POST-OP ACTIVITY RESTRICTIONS, ARE BELIEVED TO HAVE CONTRIBUTED TO THE NON-UNION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANX SPINAL FIXATION SYSTEM | PEDICLE SCREW SPINAL SYSTEM | MNI | LANX, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention | PLIF CAGE: (B)(4)| RODS AND SET SCREWS: (B)(4) |