FDA Adverse Event
Malfunction
Summary report: N
COFLEX INTERLAMINAR TECHNOLOGY
MDR report key: 4360904
·
Received December 19, 2014
Report
- Report Number
- 3005725110-2014-00009
- Event Type
- Malfunction
- Date Received
- December 19, 2014
- Date of Event
- April 29, 2014
- Report Date
- December 19, 2014
- Manufacturer
- PARADIGM SPINE GMBH
- Product Code
- NQO
- PMA / PMN Number
- P110008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REVISION SURGERY DUE TO COFLEX WING BREAKAGE - PATIENT HAD SOME LOW BACK PAIN, WING OF THE DEVICE NOTED TO BE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837866 | COFLEX INTERLAMINAR TECHNOLOGY | PROSTHESIS SPINOUS PROCESS SPACER | NQO | PARADIGM SPINE GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |