MAUDE Adverse Event Report: CHOICESPINE, LLC CHOICESPINE AMBASSADOR; AMBASSADOR PLATE 3L, 42

Model Number	05-100-03-0042
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Thank you for you feedback regarding the screw backout issue you experienced with the ambassador system.Engineering investigation and evaluation was conducted using the information and imaging provided.Visual confirmation of screw backout was noted via the radiographic imaging.This issue has been observed during benchtop testing and clinical usage for a variety of different root causes such as: · cam failure, rotation, or disassociation.· cam was not locked properly.· the screw was not fully seated.· the screw had insufficient purchase of the bone.· bone quality or patient anatomy.In this specific instance, a true definitive root cause could not be determined because the subject hardware was not returned for investigation and limited imaging was provided.As shown in the ambassador surgical technique guide, the cam should be rotated clockwise to a 45°-90° final position (depending on screw angulation) using the torque limiting handle.
Event or Problem Description
Dr.(b)(6) relayed patient with postoperative screw migration.The migrating screws seemed to all be from the most caudal vertebral body to which the plate is fastened.Images are provided.Patient initials (b)(6); dos (b)(6) 2022.3-level acdf.Dr.(b)(6) revised the patient on (b)(6) 2024 due to the continued migration of the ambassador screw.Patient revision surgery was revised not using choicespine product.The revision surgery was to prevent esophagus or other soft tissue damage by the migrating screw.

• Brand Name: CHOICESPINE AMBASSADOR
• Common Device Name: AMBASSADOR PLATE 3L, 42
• Manufacturer (Section D): CHOICESPINE, LLC; 400 erin drive; knoxville TN 37919
• Manufacturer (Section G): CHOICESPINE.LLC; 400 erin drive; knoxville TN 37919
• Manufacturer Contact: tracy huling ; 400 erin drive; knoxville, TN 37919 ; 8652433967
• MDR Report Key: 19060347
• Report Number: 3005819474-2024-00003
• Device Sequence Number: 14920219
• Product Code: KWQ
• UDI-Device Identifier: 10885862269195
• UDI-Public: 10885862269195
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K143576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 03/11/2024

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: 05-100-03-0042
• Device Lot Number: 6341-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 64 YR
• Patient Sex: Female