Brand Name | UNIVERSAL TRACKER |
Type of Device | ORTHOPEDIC 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 |
zachary
baker
|
4100 east milham avenue |
kalamazoo, MI 49001
|
2693237700
|
|
MDR Report Key | 6871579 |
MDR Text Key | 86428074 |
Report Number | 0001811755-2017-01829 |
Device Sequence Number | 1 |
Product Code |
OLO
|
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 |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
01/31/2018 |
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 | 6000-005-000 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/02/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/22/2017 |
Initial Date FDA Received | 09/18/2017 |
Supplement Dates Manufacturer Received | 10/11/2017
|
Supplement Dates FDA Received | 01/31/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |