Brand Name | COFLEX |
Type of Device | PROSTHESIS, SPINOUS PROCESS SPACER |
Manufacturer (Section D) |
PARADIGM SPINE GMBH |
eisenbahnstrasse 84 |
|
wurmlingen 78573 |
GM 78573 |
|
Manufacturer (Section G) |
PARADIGM SPINE LLC |
eisenbahnstrasse 84 |
|
wurmlingen 78573 |
GM
78573
|
|
Manufacturer Contact |
alberto
jurado
|
eisenbahnstrasse 84 |
|
wurmlingen 78573
|
GM
78573
|
|
MDR Report Key | 5197143 |
MDR Text Key | 30336577 |
Report Number | 3005725110-2015-00005 |
Device Sequence Number | 1 |
Product Code |
NQO
|
Combination Product (y/n) | N |
PMA/PMN Number | P110008 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Type of Report
| Initial |
Report Date |
10/22/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Other
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/18/2015
|
Initial Date FDA Received | 10/30/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|