Brand Name | COFLEX INTERLAMINAR TECHNOLOGY |
Type of Device | PROSTHESIS, SPINOUS PROCESS SPACER/PLATE |
Manufacturer (Section D) |
PARADIGM SPINE GMBH |
eisenbahnstrasse 84 |
wurmlingen, 78573 |
GM 78573 |
|
Manufacturer (Section G) |
PARADIGM SPINE GMBH |
eisenbahnstrasse 84 |
|
wurmlingen, 78573 |
GM
78573
|
|
Manufacturer Contact |
alberto
jurado
|
eisenbahnstrasse 84 |
wurmlingen, 78573
|
GM
78573
|
|
MDR Report Key | 10717372 |
MDR Text Key | 212462636 |
Report Number | 3005725110-2020-00003 |
Device Sequence Number | 1 |
Product Code |
NQO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P110008 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/22/2020 |
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 |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/24/2020
|
Initial Date FDA Received | 10/22/2020 |
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;
|