Brand Name | UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT) |
Type of Device | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
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 | 11485517 |
MDR Text Key | 239827128 |
Report Number | 1220246-2021-02749 |
Device Sequence Number | 1 |
Product Code |
HSD
|
UDI-Device Identifier | 00888867234215 |
UDI-Public | 00888867234215 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K161782 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
03/15/2021 |
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
|
Device Operator |
Health Professional
|
Device Model Number | UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT) |
Device Catalogue Number | AR-9502F-36RCPC |
Device Lot Number | 19.00394 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/28/2021
|
Initial Date FDA Received | 03/15/2021 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|