MAUDE Adverse Event Report: PARAGON 28, INC GORILLA PLATING SYSTEM; 3.5 X 32 MM R3CON LOCKING PLATE SCREW

Catalog Number P50-353-3532

Device Problem Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2020

Event Type  malfunction  

Event Description

A post market clinical study identified screw backed out of plate.Clincial notes state the subject was non-complaint with weight-bearing protocol.

Manufacturer Narrative

(b)(4).

• Brand Name: GORILLA PLATING SYSTEM
• Type of Device: 3.5 X 32 MM R3CON LOCKING PLATE SCREW
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 15117179
• MDR Text Key: 297229670
• Report Number: 3008650117-2022-00093
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P50-353-3532
• Device Lot Number: AR2004037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 136 KG