MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM LAPIDUS NAIL; ORTHOPEDIC NAIL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

A published article indicated a study where reoperations occurred.The reoperation was for a hallux valgus recurrence requiring a distal chevron osteotomy.

Manufacturer Narrative

During an internal maude review, it was determined that previously selected medical device problem code was inaccurate.Updated code to be: 2993.

• Brand Name: PHANTOM LAPIDUS NAIL
• Type of Device: ORTHOPEDIC NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7207165439
• MDR Report Key: 12686454
• MDR Text Key: 278091653
• Report Number: 3008650117-2021-00122
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 01/19/2022
• 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