FDA Adverse Event
Injury
Summary report: N
COFLEX (R) INTERLAMINAR TECHNOLOGY
MDR report key: 4120860
·
Received September 23, 2014
Report
- Report Number
- 3005725110-2014-00005
- Event Type
- Injury
- Date Received
- September 23, 2014
- Date of Event
- December 5, 2012
- Report Date
- September 22, 2014
- Manufacturer
- PARADIGM SPINE GMBH
- Product Code
- NQO
- PMA / PMN Number
- P110008
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
COFLEX REMOVAL SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591220 | COFLEX (R) INTERLAMINAR TECHNOLOGY | PROSTHESIS, SPINOUS PROCESS SPACER | NQO | PARADIGM SPINE GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |