FDA Adverse Event
Malfunction
Summary report: N
TIMBERLINE LATERAL FUSION SYSTEM
MDR report key: 3878216
·
Received February 17, 2014
Report
- Report Number
- 3004485144-2014-00001
- Event Type
- Malfunction
- Date Received
- February 17, 2014
- Date of Event
- January 17, 2014
- Report Date
- January 22, 2014
- Manufacturer
- LANX, INC
- Product Code
- MAX
- PMA / PMN Number
- K103666
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE IMPLANT FRACTURED DURING INSERTION, BUT THIS WAS NOT DETECTED UNTIL SUBSEQUENT INTRA-OPERATIVE IMAGING. THE SURGEON ELECTED TO LEAVE THE DEVICE IN PLACE AND COMPLETE THE SURGERY. THERE HAVE BEEN NO REPORTS OF ADVERSE EFFECTS ARISING FROM THIS PRODUCT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99811 | TIMBERLINE LATERAL FUSION SYSTEM | INTERVERTEBRAL BODY FUSION DEVICE | MAX | LANX, INC | 8706-5008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8737-1000: INSERTER| 8737-1001: INSERTER |