Brand Name | RENAISSANCE SYSTEM |
Type of Device | STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MAZOR ROBOTICS LTD. |
pob 3140, 5 shacham st. |
north industrial park |
caesarea, 30889 00 |
IS 3088900 |
|
Manufacturer (Section G) |
MAZOR ROBOTICS LTD. |
pob 3140, 5 shacham st. |
north industrial park |
caesarea, 30889 00 |
IS
3088900
|
|
Manufacturer Contact |
ayelet
matia
|
pob 3140, 5 shacham st. |
north industrial park |
caesarea, 30889-00
|
IS
3088900
|
|
MDR Report Key | 7988187 |
MDR Text Key | 124491760 |
Report Number | 3005075696-2018-00023 |
Device Sequence Number | 1 |
Product Code |
HAW
|
UDI-Device Identifier | 07290109180267 |
UDI-Public | 07290109180267 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120812 |
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 |
10/20/2018 |
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 | TPL0038 |
Device Catalogue Number | TPL0038 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/28/2016 |
Initial Date FDA Received | 10/20/2018 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/03/2012 |
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) |
Other;
|
Patient Age | 1901 YR |
|
|