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

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 02/04/2019

Event Type  Injury  

Event Description

It was reported on 3/26/2019 that a patient underwent a bunion osteotomy procedure with the gorilla plating promo system.The original surgery occurred on (b)(6) 2018.It was reported in january 2019 that the im angle of the hallux valgus was under corrected.The plate was revised on (b)(6) 2019 to correct the im angle.During evaluation and investigation, the implant was not available for analysis.The dhr records of implants and instruments involved with the case were reviewed.All records indicate the product used was manufactured within acceptable design tolerances and there were no deviations noted that may have attributed to the failure mode.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: ORTHOPEDIC BONE PLATE
• Manufacturer (Section D): PARAGON 28, INC.; 4b inverness ct. e; suite 280; englewood CO 80112
• Manufacturer Contact: mackenzie belden ; 4b inverness ct. e.; suite 280; englewood, CO 80112 ; 8557862828
• MDR Report Key: 8568827
• MDR Text Key: 143685226
• Report Number: 3008650117-2019-00004
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 05/01/2019
• 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
• Patient Outcome(s): Required Intervention