Brand Name | HUMELOCK REVERSED |
Type of Device | REVERSE SHOULDER PROSTHESIS |
Manufacturer (Section D) |
FX SHOULDER SOLUTIONS DALLAS |
15920 addison road |
addison TX 75001 |
|
Manufacturer (Section G) |
FX SHOULDER SOLUTIONS DALLAS |
15920 addison road |
|
addison TX 75001 |
|
Manufacturer Contact |
tristan
mahler
|
15920 addison road |
addison, TX 75001
|
7137326920
|
|
MDR Report Key | 19215670 |
MDR Text Key | 341419360 |
Report Number | 3014128390-2024-00025 |
Device Sequence Number | 1 |
Product Code |
PHX
|
UDI-Device Identifier | 03701037300268 |
UDI-Public | 03701037300268 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K150488 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/30/2024 |
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 Catalogue Number | 105-3610 |
Device Lot Number | U1642 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
04/17/2024
|
Initial Date FDA Received | 04/30/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 11/01/2023 |
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 | PART: 103-0803 LOT: U0855 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 68 YR |