Brand Name | SPIN THORACIC NAVIGATION SYSTEM |
Type of Device | SPIN THORACIC NAVIGATION SYSTEM |
Manufacturer (Section D) |
VERAN MEDICAL TECHNOLOGIES, INC |
1908 innerbelt business center |
saint louis MO 63114 |
|
Manufacturer (Section G) |
VERAN MEDICAL TECHNOLOGIES, INC |
1908 innerbelt business center |
|
saint louis MO 63114 |
|
Manufacturer Contact |
christine
hardin
|
1908 innerbelt business center |
saint louis, MO 63114
|
3146598500
|
|
MDR Report Key | 9401570 |
MDR Text Key | 168814629 |
Report Number | 3007222345-2019-00019 |
Device Sequence Number | 1 |
Product Code |
JAK
|
UDI-Device Identifier | 00815686020088 |
UDI-Public | 00815686020088 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K122106 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/27/2019 |
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 Model Number | SYS-3000 |
Device Catalogue Number | SYS-3000 |
Device Lot Number | 81553151116 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/26/2018 |
Initial Date FDA Received | 12/03/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/16/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|