MAUDE Adverse Event Report: PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM; PHANTOM ACTIVCORE NAIL, 11.5 X 250MM

Model Number P31-115-2500-S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Non-union Bone Fracture (2369)

Event Date 08/09/2021

Event Type  malfunction  

Event Description

A peg was found to be backed out of a nail.1.3cm 3.5 months post implantation.There was no osseous bridging at the tibiotalar and subtalar sites reported.Notes from a ct done at 4 months post implantation suggest nonunion through tibiotalar and subtalar joints.At 5.5 months post implantation the peg was screwed back into the nail during surgery for a different procedure.

• Brand Name: PHANTOM HINDFOOT TTC/TC NAIL SYSTEM
• Type of Device: PHANTOM ACTIVCORE NAIL, 11.5 X 250MM
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 16773409
• MDR Text Key: 313632717
• Report Number: 3008650117-2023-00080
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P31-115-2500-S
• Device Catalogue Number: P31-115-2500-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• 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): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 115 KG