Brand Name | ALTIVATE ANATOMIC SHOULDER |
Type of Device | ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 46, E-PLUS |
Manufacturer (Section D) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
austin TX 78758 5445 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P. |
9800 metric blvd |
|
austin TX 78758 5445 |
|
Manufacturer Contact |
james
mcmahon
|
9800 metric blvd |
austin, TX 78758-5445
|
|
MDR Report Key | 15564032 |
MDR Text Key | 301367519 |
Report Number | 1644408-2022-01313 |
Device Sequence Number | 1 |
Product Code |
KWS
|
UDI-Device Identifier | 00190446178378 |
UDI-Public | (01)00190446178378 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K162024 |
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,Followup |
Report Date |
10/14/2022 |
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 | 521-07-246 |
Device Catalogue Number | 521-07-246 |
Device Lot Number | 892U1136 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
09/19/2022 |
Initial Date FDA Received | 10/07/2022 |
Supplement Dates Manufacturer Received | 10/06/2022
|
Supplement Dates FDA Received | 10/14/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/20/2020 |
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 |
Treatment | 520-07-000 LOT 888U1419; 520-10-000 LOT 851U1226; 520-50-318 LOT 958U1135 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 69 YR |
Patient Sex | Female |