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

Device Problem Failure to Align (2522)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change, or alter any conclusions, or information, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a surgical procedure that utilized paragon 28 gorilla plating system.The surgeon reported that the r3con locking screw was sitting proud in the distal hole of the 5 hole t plate.It was reported that the surgeon bent the plate at the compression slot, and the non-locking screw sat flush with the plate.The drill locking towers was used for the pre-drill holes.The initial reporter mentioned that the holes were drilled bi-cortical.Patient information was not reported, and a revision surgery was not stated.

• Brand Name: BABY GORILLA/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 ; 7206431300
• MDR Report Key: 10865930
• MDR Text Key: 219375563
• Report Number: 3008650117-2020-00165
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2018
• 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