MAUDE Adverse Event Report: PARAGON 28, INC BABY GORILLA®/GORILLA® PLATING SYSTEM; LATERAL TTC PLATE, STANDARD, RIGHT

Catalog Number P53-402-R101

Device Problems Fracture (1260); Unintended Movement (3026)

Patient Problems Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/15/2020

Event Type  malfunction  

Event Description

A post market clinical study identified that 2 screws backed out of a plate with evidence of non-compliance.A month later an infection was treated, antibiotic beads were placed, debridement conducted, and the screws were tightened.Post-op notes state the physician believed the infection led to non-union and broken hardware.

Manufacturer Narrative

(b)(4).

Event Description

A post market clinical follow-up identified that 2 screws backed out of a plate with evidence of patient non-compliance.A month later an infection was treated, antibiotic beads were placed, debridement conducted, and the screws were tightened.Post-op notes state the physician believed the infection led to non-union and broken hardware.

• Brand Name: BABY GORILLA®/GORILLA® PLATING SYSTEM
• Type of Device: LATERAL TTC PLATE, STANDARD, RIGHT
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 15113035
• MDR Text Key: 296801778
• Report Number: 3008650117-2022-00081
• Device Sequence Number: 1
• Product Code: HRS
• 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,Followup
• 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: P53-402-R101
• Device Lot Number: RZ199903
• 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
• Date Device Manufactured: 05/28/2020
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 84 KG