FDA Adverse Event
Injury
Summary report: N
THE LANX SPINAL FIXATION SYSTEM (SFS)
MDR report key: 4289967
·
Received November 26, 2014
Report
- Report Number
- 3004485144-2014-00021
- Event Type
- Injury
- Date Received
- November 26, 2014
- Date of Event
- January 31, 2013
- Report Date
- February 20, 2013
- Manufacturer
- BIOMET SPINE, LLC.
- Product Code
- NKB
- PMA / PMN Number
- K121940
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PORTION OF THE PATIENT'S SPINAL PROCESS FRACTURED DURING INSTALLATION OF AN ISPD DEVICE. THE SURGEON ADJUSTED THE PLATE LOCATION AND FLUOROSCOPY CONFIRMED THE PLACEMENT WAS ACCEPTABLE, AS THERE WAS ADEQUATE SOLID PLACEMENT OF THE DEVICE EVEN AFTER THE FRACTURE. THERE ARE NO PLANS FOR A REVISION SURGERY. THIS MDR IS BEING SUBMITTED AS A RESULT OF A RETROSPECTIVE COMPLAINT REVIEW CONDUCTED BY BIOMET SPINE. THIS RETROSPECTIVE REVIEW WAS COMPLETED IN RESPONSE TO AN FDA FORM 483 ISSUED TO BIOMET SPINE DURING AN FDA ON-SITE INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 769707 | THE LANX SPINAL FIXATION SYSTEM (SFS) | PEDICLE SCREW SPINAL SYSTEM | NKB | BIOMET SPINE, LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |