Brand Name | NAVLOCK |
Type of Device | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
MEDTRONIC NAVIGATION, INC |
826 coal creek circle |
louisville CO 80027 |
|
Manufacturer (Section G) |
MEDTRONIC NAVIGATION, INC |
826 coal creek circle |
|
louisville CO 80027 |
|
Manufacturer Contact |
glen
belmer
|
7000 central avenue ne rcw215 |
minneapolis, MN 55432
|
6122713209
|
|
MDR Report Key | 12624262 |
MDR Text Key | 276163600 |
Report Number | 1723170-2021-02492 |
Device Sequence Number | 1 |
Product Code |
OLO
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K124004 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
10/13/2021 |
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 |
No Information
|
Device Model Number | 9734680 |
Device Catalogue Number | 9734680 |
Device Lot Number | 200821 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/21/2021
|
Initial Date FDA Received | 10/13/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 08/21/2020 |
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) |
Other;
|
Patient Age | 21 YR |
|
|