MAUDE Adverse Event Report: CHOCIESPINE, LLC CHOICESPINE, AMBASSADOR; AMBASSADOR SCREW, VSD 4.9X14

Model Number	05-100-07-4014
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through engineering investigation using the information and imaging provided, it was determined that the backed-out screw is possibly due to incorrect usage of the screw lock (cam), failure of the screw lock (cam), or insufficient bone purchase.A true definitive root cause could not be determined.As shown in the ambassador surgical technique guide, it is advised to ensure the cam is rotated between 45 and 90°.Visual confirmation of the cam orientation will confirm appropriate functionality of the cam driver with torque limiting handle.
Event or Problem Description
Patient underwent a 1 level, c6 anterior cervical corpectomy procedure in which another company's corpectomy cage and the ambassador plate were used.At the patient's 4-month postop follow-up visit, the patient reported a recent fall and x-rays revealed that an ambassador screw migrated anteriorly out of the c5 vertebral body.Dr.Weisenthal commented that the corpectomy cage could have been about 2mm shorter which would have allowed him to seat it further.The patient was asymptomatic, but dr.Weisenthal was concerned with the patient's prognosis and decided to take the patient back for a 2nd surgery in which he did an acdf at the c4/5 level, placed an anterior cervical plate from c4 to c7, and did a posterior cervical fusion from c4 to t1.He utilized tiger shark c for the c4/5 interbody, a 3-level ambassador plate, and a competitive company for the posterior cervical screw system.

• Brand Name: CHOICESPINE, AMBASSADOR
• Common Device Name: AMBASSADOR SCREW, VSD 4.9X14
• Manufacturer (Section D): CHOCIESPINE, 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: 16586791
• Report Number: 3005819474-2023-00005
• Device Sequence Number: 20064952
• Product Code: KWQ
• UDI-Device Identifier: 10885862269485
• UDI-Public: 10885862269485
• 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 Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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: 05-100-07-4014
• Device Catalogue Number: 05-100-07-4014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Sex: Female