Brand Name | AEQUALIS PERFORM REVERSED SHOULDER SYSTEM |
Type of Device | SHOULDER PROSTHESIS SCREWDRIVER |
Manufacturer (Section D) |
TORNIER INC. |
10801 nesbitt avenue south |
bloomington MN 55437 |
|
Manufacturer Contact |
matt
kennedy
|
10801 nesbitt ave south |
bloomington, MN 55437
|
9526837482
|
|
MDR Report Key | 7297220 |
MDR Text Key | 101127863 |
Report Number | 3004983210-2018-00005 |
Device Sequence Number | 1 |
Product Code |
PHX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K161742 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/07/2018 |
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 |
Physician
|
Device Catalogue Number | MWJ127 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/07/2018
|
Initial Date FDA Received | 02/26/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
Required Intervention;
|