MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM HINDFOOT TTC/TC NAIL SYSTEM; PHANTOM ACTIVCORE NAIL

Model Number P31-102-1750-S

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

Devices are not expected to be returned for the manufacturer review/investigation; the patient requested to keep the explanted hardware.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a surgical procedure on (b)(6) 2020 that utilized paragon 28 phantom hindfoot ttc/tc nail system.The procedure went well, and the post-operative images was reported to have been great.On (b)(6) 2020, a revision surgery was performed to remove the phantom activcore nail from the patient due to fractured implant.It was reported that the patient was not compliant with the post-operative care instructions and ambulated early.The fracture was displaced and caused the proximal portion of the nail to flex beyond its tolerance which led to the breakage.

• Brand Name: PHANTOM HINDFOOT TTC/TC NAIL SYSTEM
• Type of Device: PHANTOM ACTIVCORE NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 11121718
• MDR Text Key: 225274057
• Report Number: 3008650117-2021-00001
• 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: Physician
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P31-102-1750-S
• Device Catalogue Number: P31-102-1750-S
• Device Lot Number: 5005804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR