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

Model Number P53-103-L052

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Injury (2348); Impaired Healing (2378)

Event Date 08/14/2017

Event Type  Injury  

Manufacturer Narrative

Case information including facility information was not provided by the initial reporter.The review of the device history records of the plate used during the surgery indicate that the device was manufactured according to specification and no deviations were noted for released product.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 (b)(6) 2016 that utilized a paragon 28 gorilla plating system.A medium mtp plate was used to address the bunion deformity with a mix of 3.5mm locking and non-locking screw and a 4.0mm screw as a crossing screw.The patient was said to be doing well on (b)(6) 2016 appointment.However, around (b)(6) 2016, patient reported sustaining an injury on the toe while on vacation.The patient improved with a stiff shoe however, she reported increased nerve pain in (b)(6) 2017.A ct scan was completed and showed the arthrodesis had not fully healed.At about 6 months post-operatively, an x-ray revealed the 4.0mm screw to be backed out plantarly and the plate broken.The plate broke proximally to the jig holes and directly across the joint.A revision surgery was completed on (b)(6) 2017 to remove the broken hardware and a thicker paragon 28 plate was used.Patient was said to be complaint to post-operative instructions.The post-operative protocol was 6 weeks heel weight bearing, then 2 weeks full weight bearing in a short boot with transition into stiff shoe or clog at 8 weeks post-operative this is report 2 of 2 for the incident.This report is to address the broken mtp plate.

• 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: 10834487
• MDR Text Key: 216099780
• Report Number: 3008650117-2020-00137
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P53-103-L052
• Device Catalogue Number: P53-103-L052
• Device Lot Number: JP0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 Weight: 66