FDA Adverse Event
Other
Summary report: N
LANX FUSION SYSTEM
MDR report key: 2794992
·
Received October 3, 2012
Report
- Report Number
- 3004485144-2012-00037
- Event Type
- Other
- Date Received
- October 3, 2012
- Date of Event
- September 4, 2012
- Report Date
- September 4, 2012
- Manufacturer
- LANX, INC.
- Product Code
- MQP
- PMA / PMN Number
- 102738
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE SURGEON EXPERIENCED DIFFICULTY DURING INSERTION OF THE SCREW COMPONENTS. SPECIFICALLY, THE SPACER MOVED WITHIN THE DISC SPACE DURING THE SCREW PREP STEPS LEADING TO NON-OPTIMAL SCREW PURCHASE IN THE VERTEBRAL BODIES. THIS RESULTED IN A SURGICAL DELAY OF APPROX 60 MINUTES. THE FOLLOWING DAY, THE SURGEON ELECTED TO PERFORM A POSTERIOR FUSION AS WELL, TO ADDRESS CONCERNS OVER THE NON-OPTIMAL ANTERIOR FIXATION. SURGICAL TECHNIQUE AND PRE-EXISTING PT CONDITIONS WERE REPORTED AS BEING CONTRIBUTING FACTORS TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LANX FUSION SYSTEM | INTERVERTEBRAL BODY FUSION DEVICE | MQP | LANX, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 8530-1002| 8530-0103| PREP AND INSERTION INSTRUMENTATION: 8530-0102 |