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
|
9746196359
|
|
MDR Report Key | 6185169 |
MDR Text Key | 62707591 |
Report Number | 3005725110-2016-00006 |
Device Sequence Number | 1 |
Product Code |
NQO
|
UDI-Device Identifier | 04260148898525 |
UDI-Public | (01)04260148898525(17)191231(10)2014003575 |
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 |
Risk Manager
|
Type of Report
| Initial |
Report Date |
12/19/2016 |
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 |
Physician
|
Device Expiration Date | 12/31/2019 |
Device Model Number | UQI00012 |
Device Catalogue Number | UQI00012 |
Device Lot Number | 2014003575 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/21/2016
|
Initial Date FDA Received | 12/19/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/20/2015 |
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) |
Hospitalization;
|
Patient Age | 53 YR |
Patient Weight | 57 |