Brand Name | UNIVERS VAULTLOCK GLENOID TRIAL, LARGE |
Type of Device | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
|
MDR Report Key | 15892981 |
MDR Text Key | 307999476 |
Report Number | 1220246-2022-05825 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 00888867250697 |
UDI-Public | 00888867250697 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K161108 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial,Followup |
Report Date |
12/01/2022 |
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 |
Health Professional
|
Device Model Number | UNIVERS VAULTLOCK GLENOID TRIAL, LARGE |
Device Catalogue Number | AR-9236-03PP |
Device Lot Number | S264TG000 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
11/10/2022 |
Initial Date FDA Received | 12/01/2022 |
Supplement Dates Manufacturer Received | 11/10/2022
|
Supplement Dates FDA Received | 12/01/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/27/2021 |
Is the Device Single Use? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|