FDA Adverse Event
Injury
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 2428622
·
Received January 23, 2012
Report
- Report Number
- 3004485144-2012-00005
- Event Type
- Injury
- Date Received
- January 23, 2012
- Date of Event
- December 22, 2011
- Report Date
- December 22, 2011
- Manufacturer
- LANX, INC.
- Product Code
- MNI
- PMA / PMN Number
- K043484
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT INSTRUCTIONS FOR USE LIST "EARLY OR LATE IMPLANT BLEEDING, BREAKAGE, FAILURE, LOOSENING OR MOVEMENT/MIGRATION" AS POSSIBLE COMPLICATIONS OF USE FOR THE DEVICE.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT UNDERWENT A POSTERIOR LUMBAR FUSION WITH TWO-LEVEL PEDICLE SCREW INSTRUMENTATION. A BROKEN PEDICLE SCREW WAS SUSPECTED DURING A F/U VISIT AND CONFIRMED DURING REVISION SURGERY ON (B)(6) 2011. THE SCREW FRACTURED DIRECTLY UNDER THE TULIP HOUSING. IT WAS REMOVED AND REPLACED.
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 | 46 YR | Required Intervention |