FDA Adverse Event
Malfunction
Summary report: N
IMPLANET SPINE SYSTEM
MDR report key: 5460539
·
Received February 25, 2016
Report
- Report Number
- 3007675554-2015-00002
- Event Type
- Malfunction
- Date Received
- February 25, 2016
- Date of Event
- July 9, 2015
- Report Date
- November 10, 2015
- Manufacturer
- IMPLANET
- Product Code
- NKB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCOUNT DISABLED: DESPITE NUMEROUS REMINDERS MADE TO ACCOUNT HELP DESK, WE WERE ENABLED TO SEND THE REPORT BEFORE.
Description of Event or Problem · 1
A (B)(6) WAS OPERATED ON (B)(6) 2015 FOR A POSTERIOR VERTEBRAL ARTHRODESIS (T11-L3) AND L2 VERTEBRECTOMY. A PYRAMESH CAGE WAS PLACED ON L2 VERTEBRECTOMY WITH AN ANTERIOR WAY (LOMBOTOMY). A REOPERATION WAS PERFORMED ON (B)(6) 2015. THE MATERIAL WAS DISASSEMBLED WITH AN EXTENSION OF THE MONTAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116430 | IMPLANET SPINE SYSTEM | MONOAXIAL PEDICLE SCREW | NKB | IMPLANET | DIAMETER 6 LENGTH 40 | DKNY-DKOC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |