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

Model Number P53-103-L252

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Identifying information of the part, such as the lot number of the device was not reported to paragon 28.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 on 11/15/2018 that utilized a paragon 28 gorilla plating system.The mtp plate was reported to have broken at the line of the precision guide placement.It was reported that a mtp graft was used for this case with the mtp plate.The patient was said to be non-complaint with post-operative instructions and weight bear early.The surgeon suspected possible infection however, the results were negative.It was reported that the surgeon may remove the hardware and place patient on antibiotics however, the revision was not scheduled.There was no reported harm to the patient due to the broken mtp plate.The patient is said to be a smoker and a diabetic.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: BONE PLATE
• 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: 10833918
• MDR Text Key: 226577704
• Report Number: 3008650117-2020-00130
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P53-103-L252
• Device Catalogue Number: P53-103-L252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2019
• 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