MAUDE Adverse Event Report: PARAGON 28, INC. MONSTER SCREW SYSTEM; BONE SCREW

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

Limited information has been received on this event.

Event Description

It was reported that 2 screws broke during patient use.Revision surgeries was conducted to remove the broken hardware.This is report 1 of 2.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: BONE 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: 16383941
• MDR Text Key: 309635123
• Report Number: 3008650117-2023-00033
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention