Brand Name | ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 38, E-PLUS |
Type of Device | REVERSE PROSTHESIS SHOULDER SYSTEM |
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 | 18288866 |
MDR Text Key | 329993000 |
Report Number | 1644408-2023-01785 |
Device Sequence Number | 1 |
Product Code |
PAO
|
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 |
Report Date |
12/07/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/07/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/19/2022 |
Device Catalogue Number | 521-07-238 |
Device Lot Number | 890U1015 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 11/16/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/02/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | 520-07-000 , LOT 888U1009; 520-08-000 , LOT 850U1008; 520-40-316 , LOT 876U1000 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 71 YR |
Patient Sex | Female |