Brand Name | NAVIO SURGICAL SYSTEM US |
Type of Device | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
BLUE BELT TECHNOLOGIES |
2905 northwest blvd ste 40 |
plymouth MN |
|
Manufacturer (Section G) |
BLUE BELT TECHNOLOGIES |
2905 northwest blvd ste 40 |
|
plymouth MN |
|
Manufacturer Contact |
rick
confer
|
2828 liberty ave |
suite 100 |
pittsburgh, PA 15222
|
|
MDR Report Key | 9536921 |
MDR Text Key | 182628135 |
Report Number | 3010266064-2019-00153 |
Device Sequence Number | 1 |
Product Code |
OLO
|
UDI-Device Identifier | 00885556628416 |
UDI-Public | 00885556628416 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K180271 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/19/2021 |
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 | NPFS02000 |
Device Catalogue Number | NPFS02000 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
09/30/2019 |
Initial Date FDA Received | 12/31/2019 |
Supplement Dates Manufacturer Received | 04/15/2021
|
Supplement Dates FDA Received | 04/19/2021
|
Was Device Evaluated by Manufacturer? |
No
|
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;
|
|
|