Brand Name | UNKNOWN AEQUALIS REVERSED II INSERT |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Manufacturer (Section D) |
TORNIER S.A.S. |
161 rue lavoisier |
montbonnot saint-martin 38330 |
FR 38330 |
|
Manufacturer (Section G) |
TORNIER S.A.S. |
161 rue lavoisier |
|
montbonnot saint-martin 38330 |
FR
38330
|
|
Manufacturer Contact |
anna
jusinski
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 16778817 |
MDR Text Key | 313679923 |
Report Number | 3000931034-2023-00100 |
Device Sequence Number | 1 |
Product Code |
KWS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/20/2023 |
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 |
Lay User/Patient
|
Device Catalogue Number | UNK_WTM |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/23/2023
|
Initial Date FDA Received | 04/20/2023 |
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 |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 63 YR |
Patient Sex | Female |