MAUDE Adverse Event Report: CHOICESPINE, LLC CHOICESPINE ANTERIOR CERVICAL PLATE (ACP)SYSTEM; FALCON PLATE, 1 LEVEL, 16

Model Number	AT10-1016
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned devices were visually assessed, and critical specifications were confirmed.As described in the feedback, one of the locking clips was broken.The root cause of the screw backout is the locking clip fracture.However, it is unknown if the locking clip was fractured before, during, or after implantation.Therefore, the root cause of the clip fracture cannot be determined.
Event or Problem Description
At one month post-op it was noticed on x-ray that the screw was backing out.At two months post-op the screw was back out even further.The plate was then removed.The screw retaining clip was noticed to be broken, and the half that would hold the loose screw was missing.

• Brand Name: CHOICESPINE ANTERIOR CERVICAL PLATE (ACP)SYSTEM
• Common Device Name: FALCON PLATE, 1 LEVEL, 16
• Manufacturer (Section D): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 23470560
• Report Number: 3005819474-2025-00006
• Device Sequence Number: 8807184
• Product Code: KWQ
• UDI-Device Identifier: 00840996100038
• UDI-Public: 00840996100038
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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 Lot Number: 11197-050
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male