FDA Adverse Event
Malfunction
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 4345436
·
Received December 5, 2014
Report
- Report Number
- 3004485144-2014-00015
- Event Type
- Malfunction
- Date Received
- December 5, 2014
- Date of Event
- November 12, 2014
- Report Date
- November 12, 2014
- Manufacturer
- BIOMET SPINE LLC
- Product Code
- NKB
- PMA / PMN Number
- K120399
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PRONG ON THE DISTAL TIP OF THE PEDICLE SCREW DRIVER SHAFT BROKE OFF IN A PEDICLE SCREW HEAD. THE SCREW WAS COMPLETELY INSERTED AT L5; THE BREAKAGE WAS NOT NOTICED UNTIL LOADING OF THE NEXT SCREW WAS ATTEMPTED. THE SCREW WAS REMOVED AND REPLACED WITH ANOTHER SCREW FROM THE SET. THE BROKEN TIP COULD NOT BE LOCATED AFTER THE SCREW WAS REMOVED, SO THERE IS A POTENTIAL THAT THE PATIENT RETAINED A FOREIGN BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 786366 | LANX SPINAL FIXATION SYSTEM | PEDICLE SCREW SPINAL SYSTEM | NKB | BIOMET SPINE LLC | 7704-3035 | TU00113A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |