Brand Name | NAV 5.5MM 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 | 3884987 |
MDR Text Key | 4546848 |
Report Number | 1723170-2014-00664 |
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 |
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 | 9734239 |
Device Lot Number | 100525 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/30/2014 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/30/2014
|
Initial Date FDA Received | 06/19/2014 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 07/29/2014 11/10/2015
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/25/2010 |
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 |