Brand Name | DRIVER 9735024 SOLERA 5.5/6.0 MAS CANN |
Type of Device | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MEDTRONIC NAVIGATION, INC. (LOUISVILLE) |
826 coal creek circle |
louisville CO 80027 |
|
Manufacturer (Section G) |
MEDTRONIC NAVIGATION, INC. (LOUISVILLE) |
826 coal creek circle |
|
louisville CO 80027 |
|
Manufacturer Contact |
peter
verhey
|
navigation customer quality |
826 coal creek circle |
louisville, CO 80027-9710
|
7208902515
|
|
MDR Report Key | 7144223 |
MDR Text Key | 95792461 |
Report Number | 1723170-2017-05267 |
Device Sequence Number | 1 |
Product Code |
OLO
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K124004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/25/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/22/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Catalogue Number | 9735024 |
Device Lot Number | 140530 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 04/18/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/30/2014 |
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 |