Brand Name | MAZOR X STEALTH EDITION |
Type of Device | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MAZOR ROBOTICS LTD |
5 shacham street |
p.o. box 3104 |
caesarea hefa,il 30795 67 |
IS 3079567 |
|
Manufacturer (Section G) |
MAZOR ROBOTICS LTD |
5 shacham street |
p.o. box 3104 |
caesarea hefa,il 30795 67 |
IS
3079567
|
|
Manufacturer Contact |
tricha
miles
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
7635140379
|
|
MDR Report Key | 11231261 |
MDR Text Key | 228712361 |
Report Number | 3005075696-2021-00013 |
Device Sequence Number | 1 |
Product Code |
OLO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K182077 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
01/26/2021 |
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 | TPL0059 |
Device Catalogue Number | TPL0059 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/04/2021 |
Initial Date FDA Received | 01/26/2021 |
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;
|