MAUDE Adverse Event Report: CHOICESPINE, LLC FALCON CERVICAL PLATE SYSTEM; FALCON 1 LEVEL PLATE

Model Number	AT10-1016
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient has pain when swallowing.Dr.(b)(6) informed the patient that two of the screws had backed out of the plate based on xrays.Device is still in patient waiting on revision surgery.

• Brand Name: FALCON CERVICAL PLATE SYSTEM
• Common Device Name: FALCON 1 LEVEL PLATE
• Manufacturer (Section D): CHOICESPINE, LLC; 400 erin drive; knoxville,
• MDR Report Key: 9782168
• Report Number: 3005819474-2020-00001
• Device Sequence Number: 16260758
• Product Code: KWQ
• UDI-Device Identifier: 00840996100038
• UDI-Public: 00840996100038
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AT10-1016
• Device Catalogue Number: AT10-1016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR