Brand Name | 3.0 RIO® ROBOTIC ARM - MICS |
Type of Device | STEREOTAXIC DEVICE, ROBOTICS |
Manufacturer (Section D) |
MAKO SURGICAL CORP. |
2555 davie road |
fort lauderdale FL 33317 |
|
Manufacturer (Section G) |
MAKO SURGICAL CORP. |
2555 davie road |
|
fort lauderdale FL 33317 |
|
Manufacturer Contact |
diana
rogers
|
210 centennial avenue |
centennial park, elstree |
borehamwood WD6 3-SJ
|
UK
WD6 3SJ
|
2082386500
|
|
MDR Report Key | 12446030 |
MDR Text Key | 270601288 |
Report Number | 3005985723-2021-00157 |
Device Sequence Number | 1 |
Product Code |
OLO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142530 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
12/07/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/09/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 209999 |
Device Catalogue Number | 209999 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 11/18/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/02/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Treatment Data |
Date Received: 09/09/2021 Patient Sequence Number: 1 |
|
|