FDA Adverse Event
Injury
Summary report: N
PHANTOM HINDFOOT TTC/TC NAIL
MDR report key: 16191289
·
Received January 17, 2023
Report
- Report Number
- 3008650117-2023-00017
- Event Type
- Injury
- Date Received
- January 17, 2023
- Date of Event
- July 27, 2021
- Report Date
- February 3, 2023
- Manufacturer
- PARAGON 28, INC.
- Product Code
- HSB
- PMA / PMN Number
- K201227
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H6: ADVERSE EVENT PROBLEM (ANNEX C) 4247 - THIS COMPLAINT WAS NOT ESCALATED TO ROOT CAUSE ANALYSIS. (ANNEX D) 4316 - THIS COMPLAINT WAS NOT ESCALATED TO ROOT CAUSE ANALYSIS.
Description of Event or Problem · 0
A NAIL BROKE DURING PATIENT USE. A REVISION SURGERY WAS CONDUCTED AND THE BROKEN IMPLANT WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5562 | PHANTOM HINDFOOT TTC/TC NAIL | PHANTOM ACTIVCORE NAIL, 11.5 X 300MM | HSB | PARAGON 28, INC. | P31-115-3000-S | 5005811 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |