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

Model Number	P53-402-R101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Devices are not expected to be returned for the manufacturer review/investigation.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 or Problem Description
It was reported that patient underwent surgery with a paragon 28 silverback gorilla lateral ttc plate on (b)(6) 2020.Post-operatively the plate was found broken, and the patient was reported to have stepped into a hole during recovery.As of the reporting date, the patient's ankle is over 50% fused based on ct scans.There is no loosening of screws in the talus and calcaneous.There is no revision surgery planned for this time.

• Brand Name: SILVERBACK GORILLA PLATING SYSTEM
• Common Device Name: BONE PLATE SYSTEM
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood, co
• MDR Report Key: 10291832
• Report Number: 3008650117-2020-00066
• Device Sequence Number: 2890157
• Product Code: HRS
• UDI-Device Identifier: 00889795053206
• UDI-Public: (01)00889795053206(10)PA10180001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: P53-402-R101
• Device Lot Number: PA10180001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR