MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM INTRAMEDULLARY NAIL

Model Number P30-L1-5538

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 09/12/2019

Event Type  Injury  

Manufacturer Narrative

The review of the device history records of the nail used during the surgery indicate that the implants were manufactured according to specification and no deviations were noted for released product.Devices are not expected to be returned for the manufacturer review / investigation.

Event Description

It was reported that a paragon 28 nail was implanted on (b)(6) 2018.Upon the report on (b)(6) 2019, the patient showed signs of recurrence of the initial deformity and had a reported non-union of the joint.On (b)(6) 2019, the patient underwent a surgical procedure to remove the paragon 28 phantom nail and associated screws.

• Brand Name: PHANTOM INTRAMEDULLARY NAIL
• Type of Device: INTRAMEDULLARY NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: mackenzie belden ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 9176640
• MDR Text Key: 165212320
• Report Number: 3008650117-2019-00013
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182307
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P30-L1-5538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2019
• 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