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 |
richard
younger jr
|
eisenbahnstrasse 84 |
wurmlingen 78573
|
GM
78573
|
|
MDR Report Key | 14767115 |
MDR Text Key | 294490377 |
Report Number | 3005725110-2022-00001 |
Device Sequence Number | 1 |
Product Code |
NQO
|
UDI-Device Identifier | 04260148898532 |
UDI-Public | (01)04260148898532(17)210331(10)2016000286 |
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 |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/26/2023 |
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 | 03/31/2021 |
Device Model Number | UQI00014 |
Device Catalogue Number | UQI00014 |
Device Lot Number | 2016000286 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/24/2022
|
Initial Date FDA Received | 06/22/2022 |
Supplement Dates Manufacturer Received | 01/20/2023
|
Supplement Dates FDA Received | 01/26/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/29/2016 |
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;
|
Patient Age | 29 YR |
Patient Sex | Male |
Patient Weight | 85 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | White |