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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Discoloration (2074)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

Devices are not expected to be returned for the manufacturer review/investigation.The device manufacturing and inspection records were not analyzed for the implants because identifying information such as part number, lot number, or udi were not returned.In addition, the implantation date was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

A paragon 28 lateral column fusion gorilla plate and associated screws were removed from a patient on (b)(6) 2020.The reason for the removal of the implants was not provided.However, upon removal of the implants the patient's tissue was found to be grey in color at the site where the plate was sitting.The surgeon provided information that the patient has a nickel allergy and has had a previous hardware removal of an unidentified competitor's product, which the surgeon stated may be a contributing factor to the tissue discoloration.After the removal of paragon 28 lateral column fusion plate and associated screws, an unidentified competitor's product was used to fuse the hindfoot.The patient condition is reported to be stable.

Manufacturer Narrative

Information corrected section g5 (pma/510(k) #: k190365).

• Brand Name: GORILLA/BABY GORILLA PLATING SYSTEM
• Type of Device: BONE PLATE SYSTEM
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr.; englewood CO 80112
• MDR Report Key: 10546591
• MDR Text Key: 207364374
• Report Number: 3008650117-2020-00068
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K190365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention