Brand Name | ALTIVATE ANATOMIC SHOULDER |
Type of Device | ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 50, 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 | 16015381 |
MDR Text Key | 305813978 |
Report Number | 1644408-2022-01724 |
Device Sequence Number | 1 |
Product Code |
KWS
|
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 |
Physician
|
Type of Report
| Initial |
Report Date |
12/20/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 521-07-250 |
Device Catalogue Number | 521-07-250 |
Device Lot Number | 893U1176 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/14/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/05/2021 |
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 888U1571; 520-10-000 LOT 851U1310; 520-54-318 LOT 959U1012 |
Patient Outcome(s) |
Other;
Required Intervention;
|
Patient Age | 50 YR |
Patient Sex | Male |