MAUDE Adverse Event Report: PARAGON28, INC. GORILLA PLATING SYSTEM; 4-CORNER PLATES: 2ND & 3RD, LARGE, LEFT

Model Number	P53-110-L213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient experienced a non-union, as a result a revision surgery was conducted.During the revision surgery, the plate was found broken.
Additional Manufacturer Narrative
The evaluation of the returned plate confirmed the compression slot was broken.

• Brand Name: GORILLA PLATING SYSTEM
• Common Device Name: 4-CORNER PLATES: 2ND & 3RD, LARGE, LEFT
• Manufacturer (Section D): PARAGON28, INC.; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: kate vang ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 18992040
• Report Number: 3008650117-2024-00019
• Device Sequence Number: 3051217
• Product Code: HRS
• UDI-Device Identifier: 00889795010032
• UDI-Public: 00889795010032
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K140397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P53-110-L213
• Device Catalogue Number: P53-110-L213
• Device Lot Number: PA9753002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male