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

Device Problem Compatibility Problem (2960)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

This adverse event report addresses the serious injury sustained.(b)(4).

Event Description

During a triple arthrodesis surgical procedure, failed mating part interaction between screws and plates was reported.The screws did not lock into plates after several attempts.Serious injury was sustained; bone loss was reported, and bone allograft was needed for the patient.

• Brand Name: GORILLA PLATING 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: 15568173
• MDR Text Key: 301471488
• Report Number: 3008650117-2022-00121
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female