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

Device Problems Break (1069); Noise, Audible (3273)

Patient Problem Swelling (2091)

Event Type  malfunction  

Manufacturer Narrative

The implantation date was not provided by the initial reporter.Identifying information of the part, such as the part number and lot number of the device was not reported to paragon 28.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

It was reported that the patient underwent a charcot surgical procedure utilizing paragon 28 monster medial column beaming screw.The screw was reported broken at about 13 months post-operatively.The patient was reported to be fine at 9 months post-operative and was in a frame and boot at the time.There was swelling at the site however, the surgeon believed it was due to patient's diabetes.The frame was removed (9 months) for patient to begin physical therapy.The patient's therapy included exercises involving standing on tip toes which was said to have added pressure to the construct.The patient reported hearing a clicking noise in the foot while walking and upon doctor's visit, it was discovered that the beaming screw was broken.The break was at the thread interface by the tm joint.A revision surgery was not reported.

• 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 ; 7206431300
• MDR Report Key: 10858399
• MDR Text Key: 219374615
• Report Number: 3008650117-2020-00162
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190568
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• 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: 08/28/2019
• 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