MAUDE Adverse Event Report: PARAGON 28, INC PHANTOM ACTIVCORE NAIL; PHANTOM ACTIVCORE NAIL, 11.5 X 300MM

Model Number P31-115-3000-S

Device Problems Difficult to Remove (1528); Activation Problem (4042)

Patient Problem Unspecified Infection (1930)

Event Date 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Dhr inspection signed 8/19/2020 and noted to be within specifications.All pieces were accepted with no ncr's noted.If any additional information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

Paragon 28 phantom nail was implanted (b)(6) 2020.Patient developed an infection and surgeon attempted to revise implant on (b)(6) 2021.It was reported the surgeon typically does not use an end cap, the threads of the nail are thin and fine, and they could not get the "bolts" to engage the nail.Surgeon was not able to remove the implant.Patient was prescribed antibiotics and referred to a bigger hospital downtown (b)(6) for removal.

• Brand Name: PHANTOM ACTIVCORE NAIL
• Type of Device: PHANTOM ACTIVCORE NAIL, 11.5 X 300MM
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 4406106899
• MDR Report Key: 11661123
• MDR Text Key: 245962452
• Report Number: 3008650117-2021-00082
• 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: 04/13/2021

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 Model Number: P31-115-3000-S
• Device Catalogue Number: P31-115-3000-S
• Device Lot Number: 5005811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/13/2021
• 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: 62 YR