Brand Name | EASYTECH ANATOMIC |
Type of Device | TOTAL ANATOMIC SHOULDER PROSTHESIS |
Manufacturer (Section D) |
FX SOLUTIONS |
1663 rue des majornas |
viriat, 01440 |
FR 01440 |
|
Manufacturer (Section G) |
FX SOLUTIONS |
1663 rue des majornas |
|
viriat, 01440 |
FR
01440
|
|
Manufacturer Contact |
ratsamy
thevenin
|
1663 rue des majornas |
viriat, 01440
|
FR
01440
|
|
MDR Report Key | 13168864 |
MDR Text Key | 283308952 |
Report Number | 3009532798-2021-00230 |
Device Sequence Number | 1 |
Product Code |
PKC
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/29/2021 |
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
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/28/2021 |
Initial Date FDA Received | 01/05/2022 |
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) |
Hospitalization;
|
Patient Age | 73 YR |
Patient Sex | Female |