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

Catalog Number P30-L1-5544

Device Problems Loss of or Failure to Bond (1068); Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

The review of the device history records of the part used during the surgery indicate that the implants were manufactured according to specification and no deviations were noted for released product.The affected device was not returned to paragon 28 for analysis.

Event Description

It was reported that the patient underwent a lapidus arthrodesis surgical procedure using a paragon 28 intramedullary nail on (b)(6) 2018.The nail broke with a non-union across the joint.The nail was revised on (b)(6) 2018 using three paragon 28 monster screws.The implants associated with the case were not returned for physical analysis.The dhr records of implants associated with the case were reviewed.All records indicate the implants were manufactured according to specification.

• Brand Name: PHANTOM INTRAMEDULLARY NAIL
• Type of Device: INTRAMEDULLARY NAIL
• Manufacturer (Section D): PARAGON 28, INC.; 4b inverness ct. e; suite 280; englewood CO 80112
• Manufacturer Contact: mackenzie belden ; 4b inverness ct. e.; suite 280; englewood, CO 80112 ; 7206431300
• MDR Report Key: 8100105
• MDR Text Key: 128250931
• Report Number: 3008650117-2018-00018
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170693
• 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: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: P30-L1-5544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2018
• 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