FDA Adverse Event
Injury
Summary report: N
SMARTLOX
MDR report key: 6124821
·
Received November 23, 2016
Report
- Report Number
- 3006082533-2016-00007
- Event Type
- Injury
- Date Received
- November 23, 2016
- Date of Event
- October 25, 2016
- Report Date
- November 23, 2016
- Manufacturer
- CAPTIVA SPINE
- Product Code
- KWQ
- PMA / PMN Number
- K141332
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
CAPTIVA SPINE DISTRIBUTOR REPRESENTATIVE CONTACTED CAPTIVA TO INDICATE THAT SMARTLOX PLATE AND SCREWS HAD BEEN REMOVED DURING A REVISION SURGERY. PATIENT WAS ASYMPTOMATIC, REVISION SURGERY WAS COMPLETED AND ALL HARDWARE REMOVED ON (B)(6) 2016. THE DISTRIBUTOR REPRESENTATIVE PROVIDED X-RAY IMAGES FROM THE PATIENT SHOWING A BROKEN SCREW. IT WAS NOTED IN THE X-RAY THAT THERE WAS ONLY ONE SCREW USED IN THE SUPERIOR AND INFERIOR PORTION OF THE 2-LEVEL PLATE (THE CERVICAL PLATE CONSTRUCT IS INTENDED TO HAVE TWO SCREWS PER LEVEL AS NOTED IN THE ILLUSTRATED SURGICAL TECHNIQUE). THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 774673 | SMARTLOX | SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS | KWQ | CAPTIVA SPINE | ST16018 | 06110017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |