Brand Name | AEQUALIS REVERSED II LATERAL HUMERAL INSERT |
Type of Device | AEQUALIS REVERSED II LATERAL HUMERAL INSERT |
Manufacturer (Section D) |
TORNIER SAS |
montbonnot, |
FR |
|
Manufacturer Contact |
segolene
pollet
|
161 rue lavoisier |
montbonnot, cedex 38334
|
FR
38334
|
|
MDR Report Key | 5815077 |
MDR Text Key | 189483023 |
Report Number | 3000931034-2015-00015 |
Device Sequence Number | 1 |
Product Code |
PHX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K050316 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/19/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2015 |
Device Catalogue Number | DWB996 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/19/2015
|
Initial Date FDA Received | 07/24/2015 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/01/2010 |
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 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 76 YR |