Brand Name | COFLEX INTERLAMINAR TECHNOLOGY |
Type of Device | PROSTHESIS, SPINOUS PROCESS SPACER |
Manufacturer (Section D) |
PARADIGM SPINE GMBH |
eisenbahnstrasse 84 |
wurmlingen, 78573 |
GM 78573 |
|
MDR Report Key | 9763543 |
MDR Text Key | 209412847 |
Report Number | 3005725110-2020-00001 |
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,Followup |
Report Date |
09/07/2020 |
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? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/03/2020
|
Initial Date FDA Received | 02/27/2020 |
Supplement Dates Manufacturer Received | 02/03/2020
|
Supplement Dates FDA Received | 09/07/2020
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 71 YR |
Patient Weight | 109 |
|
|