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

Model Number P53-401-L211

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

Plate broke during patient use.Patient condition was said to have caused the failure.

Manufacturer Narrative

(annex c) 4247 - this complaint was not escalated to root cause analysis.(annex d) 4316 - this complaint was not escalated to root cause analysis.Changed medical device problem code from 3190 to 1260.

• 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: 15375745
• MDR Text Key: 300585759
• Report Number: 3008650117-2022-00107
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: P53-401-L211
• Device Catalogue Number: P53-401-L211
• Device Lot Number: PA9912004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male