FDA Adverse Event
Malfunction
Summary report: N
IMPLANET SPINE SYSTEM
MDR report key: 5815379
·
Received July 22, 2016
Report
- Report Number
- 3007675554-2016-00001
- Event Type
- Malfunction
- Date Received
- July 22, 2016
- Date of Event
- July 6, 2016
- Report Date
- July 22, 2016
- Manufacturer
- IMPLANET
- Product Code
- NKB
- PMA / PMN Number
- K143731
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A (B)(6) YEARS OLD PATIENT ((B)(6)) WAS OPERATED ON (B)(6) 2015 FOR A SPONDYLOLISTHESIS L5S1. TWO MONOAXIAL SCREWS (IMPLANET SPINE SYSTEM 6 MM DIAMETER AND 40 MM LENGTH) WERE PLACED IN L5 PEDICLE. TWO MONOAXIAL SCREWS (IMPLANET SPINE SYSTEM 6 MM DIAMETER AND 35 MM LENGTH) WERE PLACED IN S1 PEDICULE. TWO 50 MM STEMS BRING TOGETHER THE PEDICULAR SCREWS ON EACH SIDE OF THE SPINE. A REOPERATION WAS PERFORMED ON (B)(6) 2016. THE MATERIAL WAS DISASSEMBLED BESIDE THE DISTAL EXTREMITIES OF THE SCREWS BROKEN IN L5 VERTEBRAE. THE MONTAGE WAS EXTENDED TO L4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469600 | IMPLANET SPINE SYSTEM | MONOAXIAL PEDICLE SCREW | NKB | IMPLANET | DIAMETER 6 LEGTH 40 | ELRC-ENTZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |