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

Model Number P20-125-015S

Device Problem Failure to Advance (2524)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 03/05/2020

Event Type  malfunction  

Manufacturer Narrative

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 lot number of the device was not provided, so the device history records could not be reviewed.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 a 2.5mm mini-monster screw was used during a surgery on (b)(6) 2020.During implantation, the screw stopped advancing into the patient's bone and was removed.It was noted at that time that the distal tip of the explant showed damage.Another screw was implanted successfully.In the post-operative followup, images of the patient's bone showed metallic fragments, allegedly from the damaged screw.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: METALLIC 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: 9941521
• MDR Text Key: 188695575
• Report Number: 3008650117-2020-00022
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190586
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P20-125-015S
• Device Catalogue Number: P20-125-015S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• 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): Other