MAUDE Adverse Event Report: PARAGON 28, INC. PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM; BONE SCREW

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

This is the first of two reports in relation to the journal article related to the patient that required additional surgery due to symptomatic hardware.During evaluation and investigation, the implants were not available for analysis.The implants are not expected to be returned for the manufacturer review/investigation.The device history records could not be reviewed because identifying information of the product was not reported to paragon 28.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

This report is being filed after the review of the following journal article: chaparro f, cárdenas pa, butteri a, pellegrini mj, carcuro g, ortiz c.Minimally invasive technique with intramedullary nail for treatment of severe hallux valgus: clinical results and surgical technique.J foot ankle.2020;14(1):3-8.The objective of this study was to describe lapidus fusion consecutive case series, evaluating clinical and radiological results and description of minimally invasive surgery (mis) technique for the first tarsometatarsal arthrodesis using an intramedullary nail.In the retrospective study, data was reviewed from patients who underwent lapidus mis procedures for hallux valgus deformity correction with a phantom® intramedullary nail from april 2018 to october 2019 in a single center with a minimum of 6 months follow-up.A patient chart and x-ray review were conducted by a single orthopedic surgeon to collect basic demographic data and deformity measurements: hallux valgus angle (hva), intermetatarsal angle (ima) and distal metatarsal articular angle (dmaa) pre and post-operatively.Retrospectively 111 patients (185 feet) with hallux valgus deformity were analyzed during the study period in which 8 patients (10 feet) met the inclusion criteria, with a mean age of 59 years, all female.Median follow-up was 16 months (9-23).There were no major complications.Only one patient needed additional surgery due to symptomatic hardware, specifically a medial interlocking screw irritating the skin, and a second patient showed no radiological signs of union albeit did not refer symptoms attributable to tmt joint non-union.

• Brand Name: PHANTOM SMALL BONE INTRAMEDULLARY NAIL SYSTEM
• Type of Device: BONE SCREW
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood, co
• Manufacturer Contact: mackenzie belden ; 14445 grasslands dr.; englewood, co ; 6431300
• MDR Report Key: 10126539
• MDR Text Key: 194313365
• Report Number: 3008650117-2020-00029
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K182307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• 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