Brand Name | XVISION SPINE SYSTEM (XVS) |
Type of Device | NAVIGATION SYSTEM WITH AUGMENTED REALITY |
Manufacturer (Section D) |
AUGMEDICS LTD |
1 ha-tsmikha st |
yokneam illit, 20692 05 |
IS 2069205 |
|
Manufacturer Contact |
tim
murawski
|
2580 northwest parkway |
elgin, il
|
7660260
|
|
MDR Report Key | 10446961 |
MDR Text Key | 204178769 |
Report Number | 3016571711-2020-00001 |
Device Sequence Number | 1 |
Product Code |
OLO
|
UDI-Device Identifier | 07290113780002 |
UDI-Public | (01)07290113780002(11)200402 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K190929 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/28/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/25/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | AMCH00005 |
Device Catalogue Number | AMCH00005 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 07/28/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 82 YR |
Patient Weight | 61 |