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

Model Number P53-103-L002

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

Patient Problem Failure of Implant (1924)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

During evaluation and investigation, the implants were not available for analysis as the implant is still in the patient.A revision surgery is expected however, the date is not determined.The device manufacturing and inspection records were analyzed for the device.No deviations were noted.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 a mtp plate broke 3 months post-operatively.Allegedly, the patient did not adhere to the surgeon's recommendation to post-operative care and rode a bicycle earlier than advised.The surgeon is planning on revising however, the date is not yet determined.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: PLATE, FIXATION, BONE
• 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: 10782988
• MDR Text Key: 216338852
• Report Number: 3008650117-2020-00075
• 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: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P53-103-L002
• Device Catalogue Number: P53-103-L002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2020
• 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