Brand Name | 6.5MM TAP (CANNULATED) |
Type of Device | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MEDTRONIC NAVIGATION, INC. |
826 coal creek circle |
louisville CO 80027 9710 |
|
Manufacturer (Section G) |
MEDTRONIC NAVIGATION, INC. |
826 coal creek circle |
|
louisville CO 80027 9710 |
|
Manufacturer Contact |
kristianna
bilan
|
826 coal creek circle |
louisville, CO 80027-9710
|
7208902338
|
|
MDR Report Key | 4485137 |
MDR Text Key | 5570168 |
Report Number | 1723170-2015-00128 |
Device Sequence Number | 1 |
Product Code |
OLO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K124004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative,company representative |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/10/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Medical Equipment Company Technician/Representative
|
Device Catalogue Number | 9734302 |
Device Lot Number | 120227 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/23/2015
|
Initial Date FDA Received | 02/04/2015 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 03/25/2015 11/10/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/27/2012 |
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 |