MAUDE Adverse Event Report: PARAGON 28, INC. PROMO; SCREW

Device Problem Positioning Problem (3009)

Patient Problems Abrasion (1689); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Identifying information, such as the part number and lot number of the device was not reported in the article.Case information including surgery date(s), or related patient information was not provided.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

A journal publication titled - proximal rotational metatarsal osteotomy as treatment of the sciatic bone - the first half of the year results at turku university central hospital (translated title) was reviewed.The article notes 2 patients that experienced irritation due to the position of the hardware which resulted into pain and abrasion.Hardware removal was reported.The original article was published in a finnish ortho/trauma journal in 2020.Patients in the study were treated between 1/1/2019 and 5/2/2020.This report addresses patient 2 of 2.There is limited information known on this event.The date of event is an educated guess based on the information from the article.

• Brand Name: PROMO
• Type of Device: SCREW
• 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: 12315541
• MDR Text Key: 266303438
• Report Number: 3008650117-2021-00104
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 08/12/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2021
• Initial Date FDA Received: 08/12/2021
• 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