Brand Name | NAVIGATION SYSTEM II - CART |
Type of Device | NEUROLOGICAL STEREOTAXIC INSTRUMENT |
Manufacturer (Section D) |
STRYKER INSTRUMENTS-KALAMAZOO |
4100 east milham avenue |
kalamazoo MI 49001 |
|
Manufacturer (Section G) |
STRYKER INSTRUMENTS-FREIBURG |
boetzingerstr. 41 |
|
freiburg D-791 11 |
|
Manufacturer Contact |
casey
metzger
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 6184835 |
MDR Text Key | 62676703 |
Report Number | 0001811755-2016-02859 |
Device Sequence Number | 1 |
Product Code |
HAW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K993239 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/23/2017 |
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 |
Health Professional
|
Device Catalogue Number | 7700-100-000 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/21/2016 |
Initial Date FDA Received | 12/19/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 02/23/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/29/2008 |
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 |
|
|