Brand Name | HUMERAL STEM MEDIUM STANDARD RIGHT |
Type of Device | NI |
Manufacturer (Section D) |
TORNIER, INC. |
bloomington MN |
|
Manufacturer Contact |
kevin
smith
|
10801 nesbitt ave south |
bloomington, MN 55437
|
9529217121
|
|
MDR Report Key | 4616140 |
MDR Text Key | 17220021 |
Report Number | 3004983210-2015-00004 |
Device Sequence Number | 1 |
Product Code |
KWH
|
Combination Product (y/n) | N |
PMA/PMN Number | K100562 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0030402 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/16/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|