MAUDE Adverse Event Report: PARAGON 28, INC BABY GORILLA/GORILLA PLATING SYSTEM; GORILLA, PLATE, ANATOMICAL FIBULAR

Device Problems Unintended Movement (3026); Separation Problem (4043)

Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It was reported that the surgeon recalled one instance of loss of correction with the use of a gorilla fibular fraction plate.The loss of correction occurred in the post-operative period when an x-ray was taken that showed a loss of fixation.

Manufacturer Narrative

Correction section b5 update.

Event Description

It was reported that the surgeon recalled one instance of loss of correction with the use of a gorilla fibular fraction plate, and the robustness of plate was underestimated and not quite strong enough to stabilize the fracture.The loss of correction occurred in the post-operative period when an x-ray was taken that showed a loss of fixation.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: GORILLA, PLATE, ANATOMICAL FIBULAR
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer (Section G): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: patricia loritz ; 14445 grasslands drive; englewood, CO 80112 ; 3032681250
• MDR Report Key: 18340515
• MDR Text Key: 331055795
• Report Number: 3008650117-2023-00125
• 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: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2023
• 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