FDA Adverse Event
Injury
Summary report: N
LANX SPINAL FIXATION SYSTEM
MDR report key: 4289944
·
Received November 26, 2014
Report
- Report Number
- 3004485144-2014-00022
- Event Type
- Injury
- Date Received
- November 26, 2014
- Date of Event
- April 12, 2013
- Report Date
- April 16, 2013
- Manufacturer
- BIOMET SPINE, LLC
- Product Code
- NKB
- PMA / PMN Number
- K120399
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
APPROX 18 MONTHS AFTER HAVING PEDICLE SCREWS IMPLANTED, THE PATIENT RETURNED TO THE SURGEON AFTER FALLING AT WORK AND EXPERIENCING PAIN. FLUOROSCOPY SHOWED BOTH SCREWS IMPLANTED AT S1 WERE BROKEN. A REVISION SURGERY WAS SUBSEQUENTLY PERFORMED TO REMOVE AND REPLACE THE TWO BROKEN SCREWS. THIS MDR IS BEING SUBMITTED AS A RESULT OF 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 |
|---|---|---|---|---|---|---|---|
| 769664 | LANX SPINAL FIXATION SYSTEM | PEDICLE SCREW SPINAL SYSTEM | NKB | BIOMET SPINE, LLC | 7712-5535 | L538455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |