Brand Name | COFLEX INTERLAMINAR TECHNOLOGY |
Type of Device | PROSTHESIS, SPINOUS PROCESS SPACER |
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 | 12908901 |
MDR Text Key | 282960574 |
Report Number | 3005725110-2021-00001 |
Device Sequence Number | 1 |
Product Code |
NQO
|
UDI-Device Identifier | 0426014898532 |
UDI-Public | (01)0426014898532(17)230531(10)2418313102 |
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
|
Source Type |
Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/01/2021 |
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
|
Device Expiration Date | 05/31/2023 |
Device Model Number | UQI00014 |
Device Catalogue Number | UQI00014 |
Device Lot Number | 2418313102 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/10/2021
|
Initial Date FDA Received | 12/01/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|