Brand Name | PHANTOM HINDFOOT TTC/TC NAIL SYSTEM |
Type of Device | EXPLANT ATTACHMENT, PHANTOM HINDFOOT |
Manufacturer (Section D) |
PARAGON 28, INC |
14445 grasslands dr |
englewood CO 80112 |
|
Manufacturer Contact |
kristina
odom
|
4500 bluestem drive apartment |
#23107 |
prosper, TX 75078
|
4054205738
|
|
MDR Report Key | 13389193 |
MDR Text Key | 284718292 |
Report Number | 3008650117-2022-00018 |
Device Sequence Number | 1 |
Product Code |
HSB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K201227 |
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 |
12/29/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/28/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | P31-958-0001 |
Device Catalogue Number | P31-958-0001 |
Device Lot Number | 91576982003020 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/25/2022 |
Date Manufacturer Received | 12/29/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 62 YR |
Patient Sex | Female |