FDA Adverse Event
Malfunction
Summary report: N
ALLEZ SPINE LAGUNA PEDICLE SCREW SYSTEM
MDR report key: 1070378
·
Received July 3, 2008
Report
- Report Number
- 3005032381-2008-00012
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 4, 2008
- Manufacturer
- ALLEZ SPINE, LLC
- Product Code
- MNI
- PMA / PMN Number
- K050060
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOCKING NUT CROSS THREADED RESULTING IN THE PARTIAL PUSH OUT OF THE SCREW SHANK FROM THE PEDICLE SCREW ASSEMBLY.
Description of Event or Problem · 1
SURGEON REPORTED A LOOSE PEDICLE SCREW/LOCKING NUT ON ONE SIDE IN A PT IMPLANTED WITH A SINGLE LEVEL PEDICLE SCREW CONSTRUCT FOR POSTERIOR LUMBAR FUSION. THE SURGEON REPORTED THAT THE MEDTRONIC CAGE IMPLANTED IN THE PT HAD CRACKED AND MIGRATED FROM ITS ORIGINAL IMPLANT SITE CAUSING THE PEDICLE SCREW TO LOOSEN. THE LOOSE PEDICLE SCREW WAS EXPLANTED AND REPLACED WITH ANOTHER MFR'S DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEZ SPINE LAGUNA PEDICLE SCREW SYSTEM | SPINAL FIXATION SYSTEM | MNI | ALLEZ SPINE, LLC | 120403-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |