MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; ANTERIOR TTC PLATE, FLAT, LEFT

Model Number P53-401-L211

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported that a plate broke post-operatively due to non-union.A revision surgery was conducted to remove the plate.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: ANTERIOR TTC PLATE, FLAT, LEFT
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7207165439
• MDR Report Key: 14663422
• MDR Text Key: 293830147
• Report Number: 3008650117-2022-00063
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P53-401-L211
• Device Catalogue Number: P53-401-L211
• Device Lot Number: PA9912004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2019
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 118 KG