MAUDE Adverse Event Report: PARAGON 28, INC. GORILLA PLATING SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

Limited information received on initial surgery date, patient information, patient signs and symptoms, and event details.

Event Description

A revision surgery was conducted due to a non-union.There is no allegation against our device.During the removal of the plate, a screw broke.Limited information received on the initial surgery.A competitor's device was used for the removal.

• Brand Name: GORILLA PLATING SYSTEM
• Type of Device: GORILLA PLATING SYSTEM
• 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: 15503077
• MDR Text Key: 300774093
• Report Number: 3008650117-2022-00118
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/28/2022

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other